BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LRG TITANIUM LIGATING CLIP

    MDR report key: 1210239 · Received October 21, 2008

    Report

    Report Number
    3005075853-2008-02499
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/21/2008. VISCOUS SILICONE, DROPPING OR EJECTED CLIP. EVALUATION SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE INSTRUMENT WAS NONFUNCTIONAL. THE INSTRUMENT WAS FOUND TO HAVE SLOW FEED DUE TO THE VISCOUS SILICONE. THE SILICONE UTILIZED TO SEAL THE INSTRUMENT HAD BECOME VISCOUS, THUS SLOWING THE FEEDING MECHANISM. ADDITIONALLY, THE INSTRUMENT EJECTED THE REMAINING CLIP. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE EJECTED CLIPS. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE THE DEVICE WAS FIRED, THE HANDLE SLOW TO OPEN, MAKING A RATCHETING SOUND. THE CLIP WAS NOT FORMED. UNK HOW THE CASE WAS COMPLETED. THE RESULT WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LRG TITANIUM LIGATING CLIP FZP ETHICON ENDO-SURGERY, LLC. NA C4FH82

    Patients

    Seq Age Sex Outcome Treatment
    1