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 |
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 |
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17 Oct 2022 |
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 |
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13 Oct 2022 |
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 |
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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 |
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 |
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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 |
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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 |
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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 |
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13 Oct 2022 |
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 |
