BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PATH

    MDR report key: 5640 · Received July 13, 1993

    Report

    Report Number
    5640
    Event Type
    Malfunction
    Date Received
    July 13, 1993
    Date of Event
    June 7, 1993
    Report Date
    June 24, 1993
    Manufacturer
    ETHICON ENDO- SURGERY
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A PIECE OF THE PLASTIC GUARD ON ETHICON 10-11MM. TROCAR BROKE OFF IN THE PERITONEUM. IT COULD NOT BE LOCATED AND WAS NOT RETREIVED FROM THE PATIENT. THE COMPANY REPRESENTATIVE WAS NOTIFIEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PATH SURGICAL TROCAR 10-11 MM DRC ETHICON ENDO- SURGERY N/A ED8460

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other