BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS SUTURE PASSER

    MDR report key: 7923016 · Received October 1, 2018

    Report

    Report Number
    3006524618-2018-00509
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    September 7, 2018
    Report Date
    March 15, 2019
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWQ
    UDI-DI
    00817470000160
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FIRSTPASS SUTURE PASSER, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT CANNOT BE ESTABLISHED AS THE PRODUCT WAS NOT RETURNED. WITHOUT THE REPORTED PRODUCT A VISUAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER COMPLAINT CANNOT BE CONFIRMED. FROM THE INFORMATION PROVIDED, HANDLE OF THE DEVICE IS NOT WORKING PROPERLY AND THE INSTRUMENT IS NOT SMOOTH WHEN IN USE. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) EXCESSIVE FORCE. (2) NORMAL WEAR AND TEAR. EXCESSIVE FORCE APPLIED TO THE DEVICE CAN RESULT IN DAMAGE TO THE DEVICE OR DAMAGE TO THE DEVICE. THE REPORTED INSTRUMENT IS A REUSABLE INSTRUMENT THEREFORE NORMAL WEAR AND TEAR CAN BE EXPECTED. THE INSTRUCTION FOR USE (IFU 62515) WERE REVIEWED AND WERE FOUND TO OUTLINE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THE IFU STATES: -AS WITH ANY SURGICAL INSTRUMENT, CARE SHOULD BE TAKEN TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THESE DEVICE, OTHERWISE, FAILURE MY RESULT. REPEATED PROCESSING OF INSTRUMENT HAS MINIMAL EFFECT ON PRODUCT LIFETIME AND FUNCTION. VISIBLE DETERIORATION SUCH AS CORROSION OR DAMAGE RESULTING FROM WEAR AND TEAR OR HANDLING IS CAUSE FOR RETIREMENT OF THE INSTRUMENT FROM FATHER USE. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. ADDITIONAL INFORMATION: ADDRESS LINE 1: BALAJI ARCADE, G-10, VIP ROAD, FOREIGN CITY AND STATE: VADODARA, GUJARAT, INTERNATIONAL ZIP CODE: 390018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HANDLE OF THE DEVICE IS NOT WORKING PROPERLY AND THE INSTRUMENT IS NOT SMOOTH WHEN IS USED. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIRSTPASS SUTURE PASSER, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS NOT ESTABLISHED. FROM THE INFORMATION PROVIDED, ¿DEVICE IS NOT WORKING PROPERLY AND THE INSTRUMENT IS NOT SMOOTH WHEN IN USE.¿ VISUAL INSPECTION OF THE FIRSTPASS SUTURE PASSER DEVICE SHOWS NO MANUFACTURING DISCREPANCIES. THE DEVICE WAS RETURNED LOADED WITH SUTURE CAPTURE AND NEEDLE. A TEST SUTURE WAS USED WITH THE NEEDLE TO PASS A STITCH INTO A TISSUE FOAM MODEL AND PERFORMED AS INTENDED. THE NEEDLE AND SUTURE CAPTURE WERE SUCCESSFULLY LOADED AND UNLOADED. CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: EXCESSIVE FORCE. NORMAL WEAR AND TEAR. INCORRECT USE. THE INSTRUCTION FOR USE WAS REVIEWED AND FOUND TO OUTLINE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THE INSTRUCTIONS FOR USE STATES: AS WITH ANY SURGICAL INSTRUMENT, CARE SHOULD BE TAKEN TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THESE DEVICE, OTHERWISE, FAILURE MY RESULT. REPEATED PROCESSING OF INSTRUMENT HAS MINIMAL EFFECT ON PRODUCT LIFETIME AND FUNCTION. VISIBLE DETERIORATION SUCH AS CORROSION OR DAMAGE RESULTING FROM WEAR AND TEAR OR HANDLING IS CAUSE FOR RETIREMENT OF THE INSTRUMENT FROM FATHER USE. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE OF THE DEVICE IS NOT WORKING PROPERLY THE INSTRUMENT IS NOT SMOOTH WHILE IS USE. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764932 FIRSTPASS SUTURE PASSER PASSER HWQ ARTHROCARE CORPORATION 22-4035 30435 00817470000160

    Patients

    Seq Age Sex Outcome Treatment
    1