BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 106327 · Received July 17, 1997

    Report

    Report Number
    1527736-1997-01694
    Event Type
    Malfunction
    Date Received
    July 17, 1997
    Date of Event
    June 3, 1997
    Report Date
    June 16, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 # 973890. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, YES; NOSE SHROUD CRACKED/BROKEN, NO. STAPLES IN NOSE, YES(1); STAPLES IN THE TRACK, YES(18) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, YES. ANALYSIS CONCLUSION: BASED UPON THE VISUAL EXAMINATION AND FUNCTIONAL TEST, THE INSTRUMENT WAS FOUND TO FUNCTION PROPERLY. THE REPORTED INCIDENT COULD NOT BE REPEATED DURING TESTING. NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "JAMMED" DURING SURGERY. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE OUR PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THE EMS JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K45X0Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other