BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPR HOOK ELECTRODE

    MDR report key: 4201639 · Received October 27, 2014

    Report

    Report Number
    1221934-2014-00463
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED AND THEREFORE A PHYSICAL EVALUATION CANNOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE FOR THE USER TO HAVE EXPERIENCED THIS FAILURE CANNOT BE DETERMINED. THIS IS A SINGLE USE DEVICE BUT IT WAS REPORTED THAT THE DEVICE HAS BEEN REPROCESSED. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. THIS FAILURE WAS REVIEWED AGAINST THE RISK ANALYSIS DOCUMENT AND FOUND TO BE WITHIN THE EXPECTED OUTCOME. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    DURING ARTHOSCOPIC KNEE SURGERY, THE TIP OF THE PRODUCT WAS BROKEN OFF. THE CASE WAS COMPLETED WITH THE BROKEN PIECE LEFT IN THE PATIENT¿S BODY. IT WAS REPORTED THAT THE PRODUCT WAS REPROCESSED. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681288 VAPR HOOK ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other