BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2875321 · Received December 17, 2012

    Report

    Report Number
    3005075853-2012-05764
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    October 13, 2012
    Report Date
    December 9, 2012
    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
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICES (A AND B) WERE RETURNED IN GOOD VISUAL CONDITION AND INSIDE THEIR ORIGINAL PACKAGES. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICES WERE TESTED FOR FUNCTIONALITY. UPON TESTING, EACH DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICES WERE FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # J91T64, EXPIRATION DATE: 6/2017, MANUFACTURING DATE: 7/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN APPLYING THE METAL CLIP ON THE CYSTIC ARTERY/DUCT THE ENDS OF THE CLIP DOESN'T MEET PROPERLY FOR A SECURE CLOSURE. IN OTHER WAY, ONE END IS LONGER THAN THE OTHER AFTER CLIPPING. THIS CAUSES THE SLIPPAGE OF ARTERY WHILE APPLYING. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4C3OT

    Patients

    Seq Age Sex Outcome Treatment
    1