BEUDAMED
    FDA Adverse Event Other Summary report: N

    J & J / ETHICON ENDO-SURGERY INC.

    MDR report key: 168403 · Received May 18, 1998

    Report

    Report Number
    MW1013841
    Event Type
    Other
    Date Received
    May 18, 1998
    Date of Event
    May 4, 1998
    Report Date
    May 18, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LINEAR STAPLER DID NOT HAVE STAPLES IN CARTRIDGE, DID NOT DISCOVER UNTIL AFTER STAPLER WAS USED. SURGEON HAD TO SEW BOWEL WITH SUTURES. POSSIBLE LEAKAGE MIGHT OCCUR. PT HAD TO HAVE A DESCENDING COLOSTOMY BECAUSE OF THIS DEFECTIVE STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J / ETHICON ENDO-SURGERY INC. LINEAR STAPLER GAG ETHICON ENDO-SURGERY, INC. 1 PROXIMATE ACCESS 55 K48VOZ & K48T21

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other