BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 84921 · Received April 16, 1997

    Report

    Report Number
    1527736-1997-00638
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Date of Event
    March 18, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: EXCESSIVE U.V. ADHESIVE ON TOP OF EJECTOR POST. FACILITY EXPERIENCED AN EVENT WITH THE 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 #971883. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, NOSE SHROUD CRACKED/BROKEN, STAPLES IN THE TRACK, AND TRIGGER ENGAGED WITH PRECOCK, YES; AND STAPLES IN NOSE, YES (1 INVERTED). FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT EXCESSIVE ADHESIVE ON TOP OF THE EJECTOR POST MAY HAVE CAUSED THE REPORTED INCIDENT DURING SURGERY. THE INSTRUMENT WAS RECEIVED WITH AN INVERTED STAPLE JAMMED IN THE CARTRIDGE NOSE AND WITH A CRACKED CARTRIDGE NOSE WELD. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO A BROKEN CARTRIDGE NOSE WELD. THE CARTRIDGE WAS DISASSEMBLED AND THE REMAINING 15 STAPLES WERE OBSERVED TO BE PROPERLY ALIGNED IN THE STAPLE TRACK. THERE WAS EXCESSIVE ADHESIVE OBSERVED ON TOP OF THE EJECTOR POST, WHICH WAS DUE TO AN ASSEMBLY ERROR. THE EXCESSIVE ADHESIVE CAUSED THE STAPLE TRACK TO BE EXPANDED, WHICH ALLOWED THE STAPLE TO INVERT RESULTING IN THE SUBSEQUENT BREAKAGE OF THE CARTRIDGE NOSE WELD AND JAMMING OF THE INSTRUMENT. THE ASSEMBLY MANAGEMENT HAS BEEN NOTIFIED OF THIS INCIDENT AND PRODUCT INQUIRY WILL MONITOR FOR ADDITIONAL 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. 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 J45P0A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other