BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 109907 · Received July 31, 1997

    Report

    Report Number
    1527736-1997-01860
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Date of Event
    July 3, 1997
    Report Date
    July 4, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    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

    FACILITY EXPERIENCED AN EVENT WITH 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 # 974226. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, YES; NOSE SHROUD CRACKED/BROKEN, NO; STAPLES IN NOSE, NO; STAPLES IN THE TRACK, YES(21) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED "STAPLES WILL NOT ADVANCE" MAY HAVE RESULTED FROM TWISTED STAPLES IN THE TRACK. DURING FUNCTIONAL TESTING THE FIRST TWO STAPLES WERE TWISTED IN THE TRACK. NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLES BECAME TWISTED IN THE TRACK. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE STAPLES WOULD NOT ADVANCE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K46C6K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other