BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1820170 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07179
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    September 20, 2007
    Report Date
    September 26, 2007
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED JAWS; DROPPING/EJECTING CLIPS. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (A) WAS RETURNED WITH THE JAWS OVER TWISTED. THE INSTRUMENT WAS CYCLED AND EJECTED 8 CLIPS DUE TO THE CONDITION OF THE JAWS. HOWEVER, NO JAMMING ISSUES WERE NOTED DURING ANALYSIS. THE INSTRUMENT LOCKED OUT AS INTENDED. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (B) WAS RETURNED WITH THE JAWS OVER TWISTED. THE INSTRUMENT WAS CYCLED AND EJECTED 13 CLIPS DUE TO THE CONDITION OF THE JAWS. HOWEVER, NO JAMMING ISSUES WERE NOTED DURING ANALYSIS. THE INSTRUMENT LOCKED OUT AS INTENDED. AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE EJECTED CLIPS. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE THERE WERE 2 DEVICES USED, THEY BOTH JAMMED DURING THE FIRING, A THIRD DEVICE WAS USED TO COMPLETE THE CASE.

    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, INC. (CINCINNATI) NA C4GO34

    Patients

    Seq Age Sex Outcome Treatment
    1