BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 82919 · Received April 3, 1997

    Report

    Report Number
    1527736-1997-00510
    Event Type
    Malfunction
    Date Received
    April 3, 1997
    Date of Event
    February 7, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: DAMAGED LIFTER AND BENT EJECTOR LEG. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC 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 #971507. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, AND TRIGGER ENGAGED WITH PRECOCK; YES. NOSE SHROUD CRACKED/BROKEN; NO. STAPLES IN NOSE; YES (2 TWISTED). STAPLES IN THE TRACK; YES (TWISTED). FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT; NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY MAY HAVE BEEN DUE TO 2 TWISTED STAPLES JAMMED IN THE CARTRIDGE NOSE. THE INSTRUMENT WAS RECEIVED WITH TWO TWISTED STAPLES JAMMED IN THE CARTRIDGE NOSE. THE STAPLES IN THE CARTRIDGE TRACK WERE ALSO OBSERVED TO BE TWISTED. NO FUNCTIONAL TESTING COULD BE PERFORMED BECAUSE THE TWISTED STAPLES COULD NOT BE REALIGNED IN THE TRACK FOR PROPER FEED TO OCCUR. THE INSTRUMENT'S CARTRIDGE WAS DISASSEMBLED AND NO DEFORMATIONS OR ANOMALIES WERE OBSERVED. NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLES HAD BECOME TWISTED IN THE TRACK. (7/7/97 CORRECTED LOT NUMBER). 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. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE 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 J42M7F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other