BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR AND SLEEVE

    MDR report key: 7656 · Received January 27, 1994

    Report

    Report Number
    7656
    Event Type
    Injury
    Date Received
    January 27, 1994
    Date of Event
    July 22, 1993
    Report Date
    August 3, 1993
    Manufacturer
    ETHICON, INC.
    Product Code
    FBQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FOLLOWING INSERTION OF THE INITIAL TROCAR DURING A LAPAROSCOPIC CHOLECYSTECTOMY IT WAS DISCOVERED THAT THE AORTA AND SMALL BOWEL HAD BEEN PERFORATED. THE SURGERY WAS IMMEDIATELY CHANGED TO A LAPAROTOMY WITH REPAIR OF THE AORTA, REPAIR OF THE SMALL BOWEL, AND AN OPEN CHOLECYSTECTOMY. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE DEVICE IS BEING HELD FOR BOTH AN INDEPENDENT AND MANUFACTURER EVALUATION BECAUSE OF A QUESTION OF DEVICE MALFUNCTION/FAILURE OF THE SAFETY SHIELD.DEVICE 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. INVALID DATA - WHETHER 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: MAYBE. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR AND SLEEVE FBQ ETHICON, INC. R1011

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention