BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 2212479 · Received April 2, 2007

    Report

    Report Number
    1527736-2007-02220
    Event Type
    Malfunction
    Date Received
    April 2, 2007
    Date of Event
    January 3, 2007
    Report Date
    February 6, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: OVER TWISTED JAWS. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED WITH THE JAWS OVER TWISTED. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE CONDITION OF THE JAWS. HOWEVER, NO JAMMING ISSUES WERE NOTED DURING ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE DAMAGED JAWS. 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.

    Description of Event or Problem · 1

    PRODUCT PROBLEM.

    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) UNK C4FT8V

    Patients

    Seq Age Sex Outcome Treatment
    1