BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA

    MDR report key: 1152723 · Received September 10, 2008

    Report

    Report Number
    1527736-2008-03730
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ER320 INSTRUMENT WAS RETURNED EMPTY AND LOCKED OUT. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED. NO TESTING COULD BE PERFORMED AS THE INSTRUMENT WAS RETURNED EMPTY. WHILE WE WERE UNABLE TO RE-CREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAP CHOLESYSTECTOMY PROCEDURE THAT THE JAWS DID NOT PROPERLY CLOSE AND THE CLIPS BOTH REMAIN OPEN IN THEIR DISTAL PART AND FELL DOWN CROSSED. THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW OTHER DEVICE. NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1