BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20

    MDR report key: 1923903 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07057
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 23, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). JAW. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. FURTHER INSPECTION FOUND THAT THE JAWS HAD BECOME YIELDED CAUSING THE CLIPS TO BE EJECTED AND MAKING THE DEVICE NON-FUNCTIONAL. POSSIBLE CAUSES FOR THE CONDITION FOUND MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WOULD NOT HOLD AFTER PLACING. IT WAS IMPOSSIBLE TO PLACE THE CLIPS BECAUSE THEY DID NOT CLOSE. ANOTHER LIKE DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4TH4P

    Patients

    Seq Age Sex Outcome Treatment
    1