BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 81422 · Received April 2, 1997

    Report

    Report Number
    1527736-1997-00435
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Date of Event
    February 26, 1997
    Report Date
    March 31, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: INSUFFICIENT CARTRIDGE NOSE WELD. FACILITY EXPERIENCED AN EVENT WITH ENDOPATH ENDOSCOPIC MULTIFIEED STAPLER WHILE PERFORMINING A LAP HERNIA REPAIR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED THIS INVESTIGATION OF THE DEVICE WHICH RETURNED "TO CO WILL PRODUCT #INQUIRY 971909. THES 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 TWISTED). FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, NO. ANALYSIS CONCLUSION : BASED UPON THE INQUIRY INFO AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED AFTER THE FIRST STAPLE WAS FIRED" DURING SURGERY MAY HAVE BEEN DUE TO AN INSUFFICIENT CARTRIDGE NOSE WELD. THE INSTRUMENT WAS RECEIVED WITH A TWISTED STAPLE IN THE CARTRIDGE NOSE AND THE CARTRIDGE NOSE WELD WAS OBSERVED TO BE SPLIT ON BOTH SIDES. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE A BROKEN CARTRIDGE NOSE WELD. THE CARTRIDGE NOSE WELD WAS EXAMINED AND THE WELD WAS OBSERVED TO BE INSUFFICENT ON ONE SIDE. IT WAS CONCLUDED THAT THE INSUFFICIENT WELD YIELDED ALLOWING THE STAPLE TO TWIST AND JAM IN THE NOSE, CAUSING THE SUBSEQUENT BREAKAGE OF THE OPPOSITE SIDE OF THE CARTRIDGE WELD. THE INSUFFICENT WELD WAS DUE TO AN ASSEMBLY ERROR. NOTE: IT WAS ORIGINALLY REPORTED THAT 2 INSTRUMENTS WERE BEING RETURNED, BUT NO 1 NEITHER. NEITHER THE INSTRUMENT NOR THE PACKAGING WAS RECEIVED FOR THE REPORTED PACKAGING ISSUE. A)THE APPROPRIATE MFG AND ENGINEERING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT AND PRODUCT INQUIRY WILL MOPNITOR FOR ADDITIONAL OCCURRENCES. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS. B) NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. THE INFO YOU PROVIDED HAS BEEN NOTED AND REVIEWED WITH THE APPROPRIATE MFG AND ENGINEERING PERSONNEL.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, IT WAS REPORTED BY THE AFFILIATE THE DEVICE JAMMED AFTER THE FIRST STAPLE WAS FIRED. THERE WAS NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other