BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 139011 · Received December 18, 1997

    Report

    Report Number
    1527736-1997-03469
    Event Type
    Malfunction
    Date Received
    December 18, 1997
    Date of Event
    November 19, 1997
    Report Date
    November 19, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC. LACEY MFG CO.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BODY ASSEMBLY BOWED, ABCD)NO; CLIP IN JAW, A)YES BCD)NO; CLIP STACK PRESSURE, AD)GOOD BC)N/A; CLIP STAGING, AD)GOOD BC)N/A; CLIP TRACK LOCATION, ABCD)GOOD; CONDITION OF CARTRIDGE COVER TABS, ABCD)GOOD AND TOTAL # CLIPS REMAINING, A)2 B)0 C)0 D)20. FUNCTIONAL TESTS & RESULTS: ANTI-BACKUP FUNCTIONAL, AD)YES CD)N/A; CLIP FORM PROPERLY, AD)YES CD)N/A; CLIP FEED PROPERLY, AD)YES BC)N/A; CYCLE APPLIER, AD)YES BC)NO AND LOCKOUT FUNCTIONAL, ABCD)YES. ANALYSIS CONCLUSION: AD)IT WAS CONCLUDED THAT APPLIERS WERE CONFORMING WITH REGARD TO CLIPS FEEDING, FIRING AND FORMING. APPLIERS WERE RECEIVED IN GOOD PHYSICAL CONDITION AND APPLIER "D" DID NOT HAVE CLIP IN JAWS. APPLIERS WERE EXAMINED AND WERE FOUND TO BE FUNCTIONAL. APPLIERS WERE CYCLED AND; A)FED, AND FORMED REMAINING 2 CLIPS WITHIN DESIGN SPECIFICATION AND WITHOUT INCIDENT. D)PROPERLY FED CLIP INTO JAWS, AND THEN FIRED AND PROPERLY FOURMED REMAINING 20 CLIPS WITHIN DESIGN SPECIFICATION AND WITHOUT INCIDENT. BC)NO CONCLUSION COULD BE REACEHD AS TO WHAT MAY HAVE CAUSED REPORTED INCIDENT "DEVICES MISFIRED" DURING SURGERY. APPLIERS WERE RECEIVED EMPTY AND LOCKED OUT. APPLIERS WERE EXAMINED AND NO ANOMALIES OR DEFORMATIONS WERE OBSERVED AND NO FUNCTIONAL TESTING COULD BE PERFORMED BECAUSE INSTRUMENTS WERE EMPTY AND LOCKED OUT. ABCD)EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A GASTRIC ESOPHAGECTOMY WHILE USING FOUR MCL20 CLIP APPLIERS THE DEVICES MISFIRED WITH CLIPS SCISSORING AND FALLING OUT OF THE CLIP APPLIERS. ALL FOUR DEVICES WERE USED TO COMPLETE THE CASE (AS THEY CONTINUED OPENING DEVICES AS THE PREVIOUS DEVICES MALFUNCTIONED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. LACEY MFG CO. NA K4879A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other