BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 140634 · Received December 28, 1997

    Report

    Report Number
    1527736-1997-03613
    Event Type
    Malfunction
    Date Received
    December 28, 1997
    Date of Event
    November 22, 1997
    Report Date
    November 30, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: CLIP IN JAWS, ABC-NO; DAMAGED JAWS, AB-YES C-NO; DAMAGED FEED BAR, ABC-NO; DAMAGED FLOOR, ABC-NO; DAMAGED HANDLE SHROUDS, ABC-NO; DAMAGED TIP SHROUDS, ABC-NO; DAMAGED TRIGGER, ABC-NO; DAMAGED TUBE, ABC-NO AND DAMAGED WELD SEAMS, ABC-NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, ABC-YES; FIRING: FEED CONFORM, AB-NO C-YES; FIRING: FEED CONFORM, AB-NO C-YES; FIRING: FORM CONFORM, AB-NO C-YES; JAWS: HOLD CLIP, AB-NO C-YES; JAWS: INSIDE WIDTH AT TIPS, A-.180 B-.180 C-.160; LOCKOUT FUNCTIONAL, ABC-YES AND NUMBER OF CLIPS FED AND FORMED, C-10. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND WOULD NOT FORM THE CLIPS PROPERLY ON TWO OF THE RETURNED INSTRUMENTS. NO CONCLUSION COULD NOT BE REACHED AS TO HOW THE DAMAGE TO THE JAWS OCCURRED. IF THE JAWS ARE TORQUED OR CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT FORM THE CLIPS PROPERLY. THE THIRD INSTRUMENT WAS RETURNED IN GOOD CONDITION. THE THIRD INSTRUMENT WAS FIRED AND IT FIRED AND FORMED THE REMAINING CLIPS AS DESIGNED WITH NO DIFFICULTIES NOTED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIP APPLIERS WERE MISFIRING. EITHER NOT CLOSING, SO CLIPS WOULD FALL OUT, OR EMPTY 2 CLIPS AT THE SAME TIME. 12/2/97 THE REP REPORTS THE FIRST 2 DEVICES WOULD NOT CLOSE AND THE CLIPS WOULD JUST FALL OUT AND THE 3RD ER220 CLIPPED THREE TIMES AND THEN WOULD NOT RELEASE THE CLIPS. THERE IS NO OTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA K47R3X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other