BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON

    MDR report key: 41753 · Received September 19, 1996

    Report

    Report Number
    41753
    Event Type
    Other
    Date Received
    September 19, 1996
    Date of Event
    August 13, 1996
    Report Date
    September 16, 1996
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LAPAROSCOPIC APPENDECTOMY IN WHICH AN ENDOSCOPIC LINEAR CUTTER WAS USED. IT WAS NOTED, POST PROCEDURE, A LARGE AMOUNT OF RED DRAINAGE FROM THE SURGICAL SITE. THE PT WAS RETURNED TO SURGERY AND WAS FOUND TO BE BLEEDING A SLOW PERSISTENT STREAM FROM THE STAPLE LINE. A CLAMP AND A ENDOLOOP WAS USED TO STOP THE BLEEDING. PT WAS THEN RETURNED TO THE RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO SURGERY EZ35B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other