BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 139587 · Received December 19, 1997

    Report

    Report Number
    1527736-1997-03523
    Event Type
    Malfunction
    Date Received
    December 19, 1997
    Date of Event
    November 19, 1997
    Report Date
    November 21, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED WITH NO LOT ID. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, ABCDEF)YES; NOSE SHROUD CRACKED/BROKEN, ADEF)NO BC)YES; STAPLES IN NOSE, ADE)NO BCF)YES; STAPLES IN THE TRACK, ABE)NO F)8 AND TRIGGER ENGAGED WITH PRECOCK, ABCDEF)YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, ABCDE)NO F)YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED "STAPLER FIRED WELL INITIALLY THEN FAILED TO FEED STAPLES" DURING SURGERY OCCURRED DUE TO A SEPARATED NOSE WELD IN INSTRUMENTS (B) AND (C) AND TO AN INCLINED STAPLE IN THE NOSE OF INSTRUMENT (B) AND A TWISTED STAPLE IN THE NOSE OF INSTRUMENT (B). NO CONCLUSION COULD BE REACHED AS TO IF THE STAPLES JAMMED IN THE NOSE OF THE DEVICES CAUSED THE NOSE WELD TO YIELD OR IF THE YIELDED NOSE WELDS CAUSED THE STAPLES TO BECOME JAMMED IN THE NOSE. INSTRUMENTS (A), (D), AND (E) WERE REC'D EMPTY IN GOOD CONDITION. INSTRUMENT (F) WAS CYCLED AND FIRED THE REMAINING 9 STAPLES WELL FORMED INTERMITTENTLY DUE TO INTERFERENCE WITH THE DRIED BODY FLUIDS IN THE CARTRIDGE NOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC HERNIA REPAIR THE EMS STAPLER FIRED WELL INITIALLY THEN FAILED TO FEED STAPLES THEREAFTER (X6). 11/21/97 REP REPORTS SIX EMS STAPLERS WERE USED AND WITH EACH STAPLER THE FIRST STAPLE FIRED WITHOUT DIFFICULTY AND THEN JAMMED. A SEVENTH, NEW EMS WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other