BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 97529 · Received June 10, 1997

    Report

    Report Number
    1527736-1997-01187
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, A,B, YES. NOSE SHROUD CRACKED/BROKEN, A,B NO. STAPLES IN NOSE A,B. YES. STAPLES IN THE TRACK, A,B. YES. TRIGGER ENGAGED WITH PRECOCK A,B, YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, A,B, YES. ANALYSIS CONCLUSION: A,B)BASED UPON THE INQUIRY INFO RECEVIED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENTS WERE CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INSTRUMENTS WERE EXAMINED, WERE FOUND TO BE FUNCTIONAL, AND WERE CYLCED, FIRED, AND PROPERLY FORMED; A)THE REMAINING 17 STAPLES WITHOUT INCIDENT. B)THE REMAINING 12 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENTS "DID NOT FIRE" AND "JAMMED" DURING SURGERY. A,B)EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    DURING A T.E.P, PROCEDURE THE EMS USED TO SECURE MESH ON THE THIRD AND FOURTH FIRING DID NOT STAPLE. THE FIFTH TEST FIRING INTO A TOWEL DID NOT FIRE. THE SIX FIRING JAMMED AND A SECOND EMS WAS OPENED. DURING USE OF THE SECOND EMS, THE FOURTH AND FIFTH FIRING DID NOT STAPLE. THE SIXTH TEST FIRING INTO GAUZE DID FIRE AS DID THE SEVENTH AND EIGHTH. THE PROCEDURE WAS COMPLETED WITH THE SECOND EMS INSTRUMENT. 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 H40K59

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other