BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 231735 · Received July 12, 1999

    Report

    Report Number
    1527736-1999-03827
    Event Type
    Malfunction
    Date Received
    July 12, 1999
    Date of Event
    June 15, 1999
    Report Date
    June 21, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (2) EMS DEVICES WERE USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. THE SURGEON STATED THAT THE STAPLES JAMMED AND WERE MALFORMED. THERE WERE (4) EMS DEVICES USED AND THE CASE WAS COMPLETED WITH A COMPETITOR'S STAPLER. THERE WAS AN EXTENDED OR TIME, BUT REP WAS UNCERTAIN HOW LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLER GAG ETHICON ENDO-SURGERY, INC. S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other