BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 256162 · Received December 20, 1999

    Report

    Report Number
    1527736-1999-06621
    Event Type
    Malfunction
    Date Received
    December 20, 1999
    Date of Event
    December 13, 1999
    Report Date
    December 13, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (2) ER420 WERE USED DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SURGEON FIRED AN ER420 ONCE ONTO A VESSEL AND IT WORKED CORRECTLY. WHEN THE NEW CLIP ADVANCED INTO THE JAWS IT SHOT OUT OF THE INSTRUMENT. THE NEXT CLIP ADVANCED CORRECTLY AND THE SURGEON PLACED IT ONTO THE VESSEL BUT THE NEXT CLIP ADVANCED AND SHOT OUT OF THE INSTRUMENT MULTIPLE TIMES. THE SURGEON ASKED FOR ANOTHER ER420 TO BE OPENED. THIS SECOND DEVICE FIRED CORRECTLY TWO TIMES THEN ALSO BEGAN TO SHOOT THE CLIPS OUT OF THE JAWS. THE SURGEON ASKED FOR THE ENDO STAPLER THAT HAD BEEN USED ACROSS THE RENAL VEIN. THE SCRUB TECH TOOK THE SECOND ER420 TO THE BACK TABLE AND FIRED IT MULTIPLE TIMES. THE CLIPS SHOUT OUT OF THE INSTRUMENT FOR THE FIRST 2-3 CLIPS THEN REMAINED IN THE JAWS. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other