BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 81322 · Received March 31, 1997

    Report

    Report Number
    1527736-1997-00414
    Event Type
    Malfunction
    Date Received
    March 31, 1997
    Date of Event
    February 26, 1997
    Report Date
    March 31, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D6: DEVICE RETURNED WITH NO LOT ID. RESULTS OF EVALUATION; CONCLUSION; BASED ON THE FUNCTIONALITY TESTING IT WAS CONFIRMED THAT THE INSTRUMENT LEAKED AROUND THE O-RING AREA OF THE SLEEVE HOUSING. NO CONCLUSION COULD BE REACHED AS TO HOW THIS OCCURRED.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE 511S TROCAR MALFUNCTIONED DURING THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 3/6/97 1015 REPORTED THE INSTRUMENT "WOULD NOT HOLD IN GAS." IT WAS LEAKING PNEUMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other