BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC ARTICULATING MULTIFIED STAPLE

    MDR report key: 81183 · Received April 2, 1997

    Report

    Report Number
    1527736-1997-00456
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Report Date
    April 2, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: TWISTED STAPLES JAMMED IN THE CARTRIDGE NOSE, STAPLES REMOVED, INSTRUMENT CYCLED, FIRED AND PROPERLY FORMED THE REMAINING THREE STAPLES. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC ARTICULATING MULTIFIRED STAPLER WHILE PERFORMING A LAP HERNIA REPAIR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971389. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ARTICULATION, PRECOCK FUNCTIONAL, STAPLE COUNT, AND SWIVEL; YES. STAPLE COUNT; 4. FUNCTIONAL TESTS & RESULTS: CYCLED THE INSTRUMENT; YES. ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY MAY HAVE BEEN DUE TO A TWISTED STAPLE IN THE CARTRIDGE NOSE WHICH CAUSED THE INSTRUMENT TO JAM. THE INSTRUMENT WAS RECEIVED WITH A TWISTED STAPLE JAMMED IN THE CARTRIDGE NOSE. THE TWISTED STAPLE WAS REMOVED FROM THE NOSE AND THE INSTRUMENT WAS CYCLED, FIRED, AND PROPERLY FORMED THE REMAINING 3 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLE HAD BECOME TWISTED IN THE NOSE. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE, AND FORM CORRECTLY. THE INSTRUMENT'S STAPLES MAY BECOME TWISTED WITHIN THE CARTRIDGE TRACK AND THE CARTRIDGE NOSE IF THE INSTRUMENT SUSTAINS A BLUNT TRAUMA. THE INSTRUMENT'S STAPLES MAY MALFORM OR REFLECT IF FIRED INTO A HARD OBJECT, SUCH AS BONE. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THAT STAPLER JAMMED AD STAPLES WOULD NOT FORM. A SECOND STAPLER WAS PULLED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC ARTICULATING MULTIFIED STAPLE ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA J43C7F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other