BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 55206 · Received December 10, 1996

    Report

    Report Number
    1527736-1996-00629
    Event Type
    Malfunction
    Date Received
    December 10, 1996
    Date of Event
    November 6, 1996
    Report Date
    December 9, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC BLADDER NECK SUSPENSION, STAPLER JAMMED AND WOULD NOT FIRE. ANOTHER WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO PT. 11/15/96 0906 SURGEON CALLED BACK AND STATED AFTER APPROX 10-12 STAPLES FIRING, IT SEEMED LIKE THERE WERE NO STAPLES LEFT IN THE INSTRUMENT. ANOTHER WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA J308H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other