BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 85078 · Received April 16, 1997

    Report

    Report Number
    1527736-1997-00629
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Report Date
    April 16, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: EXCESSIVE WELD CAUSED THE YIELDING OF THE CARTRIDGE TU BE CRIMP UPON THE INITIAL FIRING OF THE INSTRUMENT, MAKING THE DEVICE NONFUNCTIONAL.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 #971815. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS AND RESULTS: HEAD ROTATES: YES. NOSE SHROUD CRACKED/BROKEN: NO. STAPLES IN NOSE: NO. STAPLES IN THE TRACK: YES. TRIGGER ENGAGED WITH PRECOCK: YES. FUNCTIONAL TESTS AND 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 AN EXCESSIVE CARTRIDGE WELD. THE INSTRUMENT WAS RECEIVED WITH A YIELDED CARTRIDGE TUBE CRIMP AND NO FUNCTIONAL TESTING COULD BE PERFORMED. THE INSTRUMENT WAS DISASSEMBLED AND THE TUBE APPEARED TO HAVE BEEN CRIMPED SUFFICIENTLY. THE CARTRIDGE WELD WAS OBSERVED TO BE EXCESSIVE, WHICH WOULD HAVE CAUSED OR SUBSEQUENT YIELDING OF THE CARTRIDGE TUBE CRIMP WHEN THE INSTRUMENT WAS FIRED, DUE TO THE TIGHTNESS OF THE STAPES IN THE TRACK NOSE. THERE WERE 19 STAPLES REMAINING. THE EXCESSIVE CARTRIDGE WELD WAS DUE TO AN ASSEMBLY ERROR. THE ASSEMBLY MANAGEMENT HAS BEEN NOTIFIED OF THIS INCIDENT AND PRODUCT INQUIRY WILL MONITOR FOR ADD'L OCCURRENCES. 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 AFTER FIRING THE FIRST STAPLE. THE DEVICE DID NOT FIRE AFTER IT BECAME JAMMED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG EES-JUAREZ NA H40174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN