BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 100924 · Received June 25, 1997

    Report

    Report Number
    1527736-1997-01427
    Event Type
    Malfunction
    Date Received
    June 25, 1997
    Date of Event
    May 28, 1997
    Report Date
    June 25, 1997
    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

    Additional Manufacturer Narrative · 1

    EES #.973901-J. 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, YES; NOSE SHROUD CRACKED/BROKEN, YES; STAPLES IN NOSE, YES(4); STAPLES IN THE TRACK, YES(7) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, NO. ANALYSIS CONCLUSION: BASED ON THE INQUIRY RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED "DEVICE JAMMED" DURING SURGERY WAS DUE TO A CRACKED CARTRIDGE NOSE. NO CONCLUSION COULD BE REACHED AS TO HOW THE NOSE HAD CRACKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A COOPERS LIGAMENT PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED. 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 K4B022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other