BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HZ APPLIER ML 8" CVD

    MDR report key: 12245102 · Received July 29, 2021

    Report

    Report Number
    3011137372-2021-00210
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 26, 2021
    Report Date
    July 26, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704710137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. IT WAS ALSO FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS. IT CAN THEN BE STATED THAT THE ALLEGED NON-CONFORMANCE INCITING THIS COMPLAINT WAS NOT DUE TO AN ERROR IN TECOMET - KENOSHA'S MANUFACTURING PROCESS. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A (B)(4) LOT IN APRIL OF 2018. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT IT HAS ADDITIONAL LASER MARKING OF A DOT MATRIX CODING ON ITS HANDLE STEM NEXT TO THE HORIZON LOGO , WHICH IS NOT PERFORMED AT THIS FACILITY AT THIS TIME. FUNCTION TESTING AS PERFORMED AT TIME OF PRODUCTION WAS PERFORMED AND THIS INSTRUMENT IS ABLE TO PICK-UP, RETAIN, CLOSE AND RELEASE MULTIPLE CLIPS WITHOUT ANY ISSUES NOTED. 6 CLOSED CLIPS WERE MEASURED , AND THEY WERE ALL WITHIN THE TOLERANCE SPECIFICATION OR .0114 MAX GAP FOR LEG GAP@ .005, .0057, .0058, .0062, .0063,.0062 AND .0143 MAX. GAP FOR EYE GAP @.0021, .0024 , .0025, .0022, .0024. WE ARE UNABLE TO VALIDATE THIS COMPLAINT SINCE WE WERE UNABLE TO REPLICATE THE ALLEGED ISSUE. ALL (B)(4) INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS , NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED.

    Description of Event or Problem · 0

    ALLEGED ISSUE: INFORMALLY IN SURGERY ROOMS THEY INFORM ME THAT THE CLIPS DID NOT CLOSE SINCE THE CLAMP WAS NOT IN GOOD CONDITION. THE CLIPS HAVE BEEN USED WITHOUT ANY PROBLEM WITH OTHER CLAMPS. I HAVE NOT RECEIVED A FORMAL QUALITY REPORT FROM THE INSTITUTION. THE CLAMP WAS REMOVED AND THE APPLIER IS AVAILABLE TO BE SHIPPED PHYSICALLY. MEDICAL INTERVENTION WAS NECESSARY BUT PATIENT IS FINE, NO PATIENT HARMED WAS REPORTED. I DO NOT HAVE MORE DETAILS, THE CLIENT DOES NOT HAVE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: INFORMALLY IN SURGERY ROOMS THEY INFORM ME THAT THE CLIPS DID NOT CLOSE SINCE THE CLAMP WAS NOT IN GOOD CONDITION. THE CLIPS HAVE BEEN USED WITHOUT ANY PROBLEM WITH OTHER CLAMPS. I HAVE NOT RECEIVED A FORMAL QUALITY REPORT FROM THE INSTITUTION. THE CLAMP WAS REMOVED AND THE APPLIER IS AVAILABLE TO BE SHIPPED PHYSICALLY. MEDICAL INTERVENTION WAS NECESSARY BUT PATIENT IS FINE, NO PATIENT HARMED WAS REPORTED. I DO NOT HAVE MORE DETAILS, THE CLIENT DOES NOT HAVE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143996 HZ APPLIER ML 8" CVD APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN914973 06F1752527 24026704710137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention N/A.