BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 97534 · Received June 10, 1997

    Report

    Report Number
    1527736-1997-01193
    Event Type
    Malfunction
    Date Received
    June 10, 1997
    Date of Event
    May 12, 1997
    Report Date
    June 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A HERINA REPAIR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETEDITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972966. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES YES, NOSE SHROUD CRACKED/BROKEN NO, STAPLES IN NOSE YES, STAPLES IN THE TRACK YES (17), TRIGGER ENGAGED WITH PRECOCK YES. FUNCTIONAL TESTS & RESULTS: CYLCED INSTRUMENT YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, A VISUAL INSPECTION AND FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO HOW THE INSTRUMENT BECAME JAMMED DURING SURGERY. ONE CLOSED STAPLE WAS IDENTIFIED AND REMOVED FROM THE CARTRIDGE NOSE ASSEMBLY. UPON REMOVAL OF THE STAPLE, THREE STAPLES WERE FIRED AND WERE FORMED PROPERLY. THE INSTRUMENT MISFIRED ON THE FOURTH CYLCLE, BUT THEN FIRED THE REMAINING 12 STAPLES PROPERLY FORMED. NO CONCLUSION COULD BE REACHED REGARDING THE CAUSE OF THE MISFIRING DURING TESTING. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE THE PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A HERNIA REPAIR PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA KCJHRCA097C07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other