BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC ARTICULATING MULTIFEED STAPLER

    MDR report key: 86319 · Received April 22, 1997

    Report

    Report Number
    1527736-1997-00720
    Event Type
    Malfunction
    Date Received
    April 22, 1997
    Date of Event
    March 25, 1997
    Report Date
    April 22, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ENDOSCOPIC ARTICULATING MULTIFEED 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 #972008. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ARTICULATION, ROTATION, AND SWIVEL, AB) YES; PRECOCK FUNCTION, A) YES B)NA; AND STAPLE COUNT, A)7 B)3. FUNCTIONAL TESTS & RESULTS: CYCLED THE INSTRUMENT, AB)YES. ANALYSIS CONCLUSION: AB) BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST; A) IT WAS CONCLUDED THAT THE INSTRUMENT MAY HAVE BEEN DRY FIRED CAUSING THE STAPLE TO JAM BETWEEN THE HOLDER AND THE BACK OF THE ANVIL. THE INSTRUMENT WAS RECEIVED IN GOOD PHYSICAL CONDITION AND WAS CYCLED AND FIRED 5 STAPLES OF WHICH NONE FORMED PROPERLY. THE CARTRIDGE WAS DISASSEMBLED AND A FORMED STAPLED WAS FOUND DEEP WITHIN THE CARTRIDGE UNDER THE ANVIL WHICH CAUSED THE STAPLES TO MALFORM. B) IT WAS CONCLUDED THAT THE TRIGGER MAY HAVE BROKEN DUE TO INSUFFICIENT PLASTIC FOR THE APPLIED LOAD. THE INSTRUMENT WAS RECEIVED WITH A BROKEN TRIGGER. A PIECE OF THE BROKEN TRIGGER WAS RECEIVED IN A SEPARATE BAG. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO A BROKEN TRIGGER. NOTE: IT WAS ORIGINALLY REPORTED THAT 3 INSTRUMENTS WERE BEING RETURNED, BUT ONLY 2 WERE RECEIVED. A) THE INSTRUMENT IS NOT DESIGNED TO BE FIRED WHILE NOT IN TISSUE OR A GAUZE SIMULATION OF TISSUE. ONCE THE STAPLE IS FORMED, THERE IS NO MEDIA TO PULL THE STAPLE OUT OF THE TIP OF THE INSTRUMENT. B) MODIFICATIONS HAVE BEEN HAVE MADE TO THE DESIGN TO INCREASE THE CROSS SECTIONAL THICKNESS OF THE TRIGGER. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE INSTRUMENTS WERE USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THREE DIFFERENT INSTRUMENTS WERE USED DURING THE CASE. ON ONE INSTRUMENT, THE STAPLES WOULD NOT RELEASE FROM THE INSTRUMENT. ON ANOTHER INSTRUMENT, THE FIRING MECHANISM WOULD NOT CLOSE TO ALLOW STAPLE FORMATION. ON THE THIRD INSTRUMENT, THE ARTICULATING JOINT BROKE. ONLY TWO INSTRUMENTS BEING RETURNED. CASE COMPLETED WITH AN OMS20. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC ARTICULATING MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA H40G5W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other