BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 317369 · Received February 21, 2001

    Report

    Report Number
    1527736-2001-00835
    Event Type
    Malfunction
    Date Received
    February 21, 2001
    Date of Event
    November 27, 2000
    Report Date
    December 5, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) EMS WAS USED DURING AN INGUINAL HERNIA PROCEDURE. IT WAS REPORTED BY THE REP THAT THE EMS WAS USED FOR MESH FIXATION. THE EMS STAPLER DID NOT FIRE AFTER FEW FIRING. ANOTHER DEVICE WAS OPENED TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6692 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLERS - ENDOSCOPIC GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other