BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1252963 · Received December 9, 2008

    Report

    Report Number
    1527736-2008-03445
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 5, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (A) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT WAS FUNCTIONAL. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (B) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT WAS FUNCTIONAL. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, MISFIRE-IT DID NOT FIRE NOR CLAMP TISSUE. UNK HOW CASE WAS COMPLETED. 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 NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4G43G

    Patients

    Seq Age Sex Outcome Treatment
    1