BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ROTATING MULITPLE CLIP APPLIER

    MDR report key: 82294 · Received January 16, 1997

    Report

    Report Number
    1527736-1997-00044
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Report Date
    January 16, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: CARTRIDGE NOSE WELD YIELDED. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A UNK. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971921. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSEPCTIONS & RESULTS: HEAD ROTATES, NOSE SHROUD CRACKED/BROKEN, STAPLES IN THE TRACK, AND TRIGGER ENGAGED WITH PRECOCK, YES; STAPLES IN NOSE, 2 PARTIALLY FORMED. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY MAY HAVE BEEN DUE TO 2 PARTIALLY FORMED STAPLES JAMMED IN THE CARTRIDGE NOSE AND A YIELDED CARTRIDGE NOSE WELD. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO A YIELDED CARTRIDGE NOSE WELD AND NO CONCLUSION COULD BE REACHED AS TO HOW THE 2 PARTIALLY FORMED STAPLES HAD BECOME JAMMED IN THE CARTRIDGE NOSE. IT WAS CONCLUDED THAT THE 2 PARTIALLY FORMED STAPLES JAMMED IN THE CARTRIDGE NOSE HAD CAUSED THE CARTRIDGE NOSE WELD TO YIELD. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE FEEDING OF MULTIPLE STAPLES INTO THE NOSE MAY OCCUR IF THE FIRING CYCLE STROKE IS NOT COMPLETED AND THE INSTRUMENT IS REFIRED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THE CLIPS DO NOT HOLD. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ROTATING MULITPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other