BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 255441 · Received December 16, 1999

    Report

    Report Number
    1527736-1999-06551
    Event Type
    Malfunction
    Date Received
    December 16, 1999
    Date of Event
    November 17, 1999
    Report Date
    November 23, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE (1) EMS WAS USED DURING AN INGUINAL HERNIA PROCEDURE. IT WAS REPORTED THAT THE STAPLER LOCKED ON THE FOURTH SHOT. THE SURGICAL PROCEDURE WAS DELAYED (15) MINUTES. THERE WAS BLEEDING UNTIL THE NEW STAPLER WAS USED BUT NO SERIOUS CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLERS - ENDOSCOPIC GAG ETHICON ENDO-SURGERY, INC. NA L4CE1W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other