BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1211901 · Received October 23, 2008

    Report

    Report Number
    3005075853-2008-02541
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 2, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DROPPING OR EJECTED CLIP. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT AS INTENDED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. 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 MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, JAMMING OCCURRED AND THE CLIP EJECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1