BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 141412 · Received December 31, 1997

    Report

    Report Number
    1527736-1997-03706
    Event Type
    Malfunction
    Date Received
    December 31, 1997
    Date of Event
    December 5, 1997
    Report Date
    December 5, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED WITH NO LOT IDENTIFICATION. DISLODGED ANVIL. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, A K01538 BC N/A; CARTRIDGE PAN IN PLACE/CONDITION, A YES/GOOD BC N/A; CONDITION OF DRIVERS, A GOOD BC N/A; LOCKOUT TABS ON PAN CONDITION, A FIRED BC N/A AND POSITION/CONDITION OF WEDGE SLEDS, A FULLY FIRED BC N/A. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, ABC GOOD; CONDITION OF CLAMPING MECHANISM, ABC DAMAGED; CONDITION OF FIRING MECHANISM, ABC GOOD; CONDITION OF KNIFE, ABC GOOD; CONDITION OF WEDGE BANDS, ABC GOOD; IS HYPER LOCKOUT CONDITION PRESENT, ABC NO AND RESULT OF ATTEMPTED FIRING, ABC GOOD. ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENTS WERE RETURNED WITH THE ANVIL DISLODGED FROM THE CLOSURE TUBE. THE ANVIL WAS RE-ALIGNED AND THE INSTRUMENTS WERE CYLCED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. NO CONCLUSON COULD BE REACHED AS TO HOW THIS DAMGE OCCURRED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DR DURING A GASTRIC RESECTION THE ETS INITIALLY FIRED ACROSS THE STOMACH BUT THEN WOULD NOT OPEN. THE STAPLER CAME UNHINGED. TWO ADD'L DEVICES WERE PULLED AND FIRED AND HE AGAIN HAD TROUBLE OPENING THE DEVICE. IN THE SURGEON'S OPINION, HE OBSERVED ON THE ETS A LITTLE PIN IN THE SLOT ON THE BARREL OF THE SHAFT THAT WHEN FIRED AND FORCED DOWN ON THICK TISSUE, IT DISLODGES THE PIN ON THE HINGE. THE DEVICE JAMMED AND WOULD NOT OPEN. HE STATES ON ONE OF THE ETS-THE PIN CAME COMPLETELY OUT OF THE DEVICE. THE CASE WAS COMPLETED BY USING THE SAME DEVICES WHICH ALL FIRED PROPERLY TO BEGIN WITH. THERE WAS NO PT CONSEQUENCE. 12/8/97 THE REP REPORTS THE PROCEDURE NAME IS EXCISION OF GASTRIC LYOMYOMA AND THE REP DISCUSSED WITH THE SURGEON THIS PARTICULAR STAPLER SHOULD NOT BE FIRED ON TISSUE THAT COMPRESSES TO GREATER THAN 2MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other