BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 100937 · Received June 25, 1997

    Report

    Report Number
    1527736-1997-01414
    Event Type
    Malfunction
    Date Received
    June 25, 1997
    Report Date
    June 24, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973328. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, YES; NOSE SHROUD CRACKED/BROKEN, NO; STAPLES IN NOSE, YES(2)MISALINGED; STAPLES IN THE TRACK, YES(15) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, YES. ANALYSIS CONCLUSION: BASED UPON THE VISUAL EXAMINATION AND FUNCTIONAL TEST PERFORMED, IT WAS CONCLUDED THAT THE INSTRUMENT JAMMED DURING SURGERY DUE TO THE MISALIGNED STAPLES IN THE NOSE. THIS WAS POSSIBLE CAUSED BY A YIELDED CARTRIDGE WELS. NO CONCLUSION COULD BE REACHED AS TO HOW THE CARTRIDGE WELD HAD YIELDED. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED AFTER THE THIRD STAPLE. THERE WAS NO PATIENT 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 J44XOJ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other