BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 262499 · Received February 11, 2000

    Report

    Report Number
    1527736-2000-00481
    Event Type
    Malfunction
    Date Received
    February 11, 2000
    Report Date
    January 14, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) EMS WAS USED DURING AN LAPAROSCOPIC HERNIA REPAIR PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE INSTRUMENT JAMMED. THE STAPLES WOULD NOT FIRE, SURGEON HAD TO MANUALLY DISLODGE STAPLES. NO SIGNIFICANT DELAYS TO PROCEDURE. OPENED A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. NO ADVERSE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLERS - ENDOSCOPIC GAG ETHICON ENDO-SURGERY, INC. NA M4FZ4T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other