• Home
  • Alert
  • FIELD CORRECTIVE ACTION (FCA) LISTING FOR OCTOBER 2022

FIELD CORRECTIVE ACTION (FCA) LISTING FOR OCTOBER 2022

The list below contains Medical Device’s Field Corrective Action for the month of October 2022. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –

  • The return of the medical device to the establishment;
  • Modification of the medical device;
  • Exchange of the medical device;
  • Destruction of medical device; or
  • Specific advice on the use of the medical device. 

If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.

 

Date received

Title of FCA

Affected

Medical Device

MDA Reference Number

MDA Registration Number

Description

Local Establishment

Contact Detail

18 Oct 2022

URGENT Product Recall - 3M™ Steri-Drape™ Surgical Drapes, Catalog Numbers 1000, 1000NS, 1000NSD, 1010, 1010NS, 1010NSD, 1020, 1020NS, 1021, 1021NS, 1030, 1030NS, 1033, 1060, 1060NS, 1061, 1061NS, 1071

3M STERI-DRAPE PLASTIC SPECIALTY DRAPES

MDA/FCA/P0108-87718925-2022

GA69973266117

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable.

CHUAH CHIEW TENG

SENIOR EHS & REGULATORY MANAGER

3M MALAYSIA SDN BHD

17 Oct 2022

 Field Safety Corrective Action - Performance of ABO grouping tests for patients and/or donors on the IH-500 instrument.

PHADIA INSTRUMENTS

MDA/FCA/P0109-98381811-2022

IVDA1670544317

In case of absence of red blood cells (RBC) sample into the Anti-A well or Anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of Empty “E” as expected.

APPHIA EU CHIA HUI

SENIOR REGULATORY & QA

BIOMARKETING SERVICES (M) SDN BHD

13 Oct 2022

5707 - FSCA - VIDAS® 3 Software v1.4.0 and v1.4.1 - 423694- Unexpected error followed by VIDAS® 3 User software shutdown

VIDAS INSTRUMENTS

MDA/FCA/P0103-11000406-2022

IVD34892104317A

In April 2022, bioMérieux received a complaint from the field related to an unexpected error after performing a calibration that was followed by a shutdown of the VIDAS® 3 Version 1.4.1 software. The customer could no longer restart the VIDAS® 3 User software and was not able to use the VIDAS® 3 instrument until the database is restored with bioMérieux support.

RUHIL ASHVIN KUMAR

ASEAN QA/RA MANAGER

BIOMERIEUX MALAYSIA SDN BHD

11 Oct 2022

Da Vinci® Si, Xi, and X Miswiring of Redundant Medical Grade Power Supply

DA VINCI SI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS3000

MDA/FCA/P0100-12349961-2022

GC74543334017

Intuitive Surgical has become aware of certain Redundant Medical Grade Power Supply (RMGPS) units in specific da Vinci Si®, Xi®, and X® Surgeon Consoles and da Vinci Si® Patient Side Carts that have been shipped with a manufacturing defect

RYAN YEO CHOON HWEE

REGULATORY AFFAIRS MANAGER, SOUTH EAST ASIA

DTG MEDICAL SDN BHD

27 Oct 2022

Engagement Failures Associated with da Vinci X/Xi SureForm 45 and SureForm 60 Staplers (PNs 480445-04, 480545-04, 480460-09)

DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000

MDA/FCA/P0114-27646467-2022

GC3810021-64842

During standard post-market surveillance activities, Intuitive has observed an increase in complaints regarding engagement failures associated with da Vinci X/Xi SureForm 45 and 60 Stapler instruments.

RYAN YEO CHOON HWEE

REGULATORY AFFAIRS MANAGER, SOUTH EAST ASIA

DTG MEDICAL SDN BHD

4 Oct 2022

Potential resistor failure in the Control Sample Board (CSB) for 9100C NXT and Aelite NXT Devices

9100C NXT ANESTHESIA SYSTEM

MDA/FCA/P0099-31006368-2022

GC59798719918

9100c NXT and Aelite NXT anesthesia devices with CSB boards manufactured prior to June 2020 have resistors that could potentially fail due to electrolytic corrosion.

LIM SOCK SIANG

DIRECTOR

GE HEALTHCARE SDN. BHD

14 Oct 2022

HVAD Pump Failure to Restart [CVG-21-Q3-21 Phase VII (Rev K)]

 

HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD)

MDA/FCA/P0107-48883760-2022

GD74345985518

CAPA 502194 was initiated on 23-Jul-2020 due to the escalation of RPI IEDF00247. RPI IEDF00247’s scope includes complaints received on pumps failing to initially start, restart or experiencing a delay in restart within the maximum number of restart attempts per the software configuration (30 restart attempts), regardless of whether the pump ultimately restarted.

LEE YOUN YOUN

REGULATORY AFFAIRS LEAD

MEDTRONIC MALAYSIA SDN BHD

3 Oct 2022

Customer Information about specific measurement values in MR Imaging, which might be wrong

SYNGO.VIA (VA20B)

MDA/FCA/P0087-64912958-2022

GB29527683718

Sporadically distance measurement values in MRI images might be wrong

In case:

1. Enhanced MRI images with rectangular FoV (Field of View) are created at the MR scanner and sent to

syngo.via, and

2. at the syngo.via system, the user rotates the images to display the images in arbitrary orientation and saves

them, and 

3. afterwards, the user exports the images to another DICOM node using MR Export Rules (interoperability

mode) 

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

13 Oct 2022

CN DC 22-03 Dimension QuikLYTE Integrated Multisensor

QUIKLYTE INTEGRATED MULTISENSOR NA+ /K+ /CL-

MDA/FCA/P0106-25269435-2022

IVDB97817211918

Siemens Healthineers has received reports of sodium calibration failures (Error code 384 - IMT failed to calibrate) with the Dimension QuikLYTE Integrated Multisensor lots listed in Table 1 due to a low sodium slope exceeding the acceptable slope limit.

LAM YEN LI

HEAD OF QUALITY & TECHNOLOGY

SIEMENS HEALTHCARE SDN BHD

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
 

Today 1119 Yesterday 5332 Week 29336 Month 49022 Visitor Counter: 117348869

  • Last Modified: 09 June 2023.
facebooktwitterinstagramyoutube
Copyright © 2023 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768