BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2792537 · Received October 16, 2012

    Report

    Report Number
    3005075853-2012-04751
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ASKU. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ASKU. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? ASKU. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? ASKU. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ASKU. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ASKU. WHAT WERE THE INDICATIONS FOR SURGERY? ASKU. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? ASKU. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). WE WERE UNABLE TO ANALYZE THE SAMPLE UTILIZED IN THE REPORTED EVENT AS THE INSTRUMENT WAS NOT RETURNED TO US. ONLY TWO MALFORMED CLIPS RECEIVED. IT COULD NOT BE DETERMINE WHAT MAY HAVE CAUSE THE REPORTED EVENT. THE INFORMATION YOU PROVIDED IS COMPILED MONITORED AND REVIEWED BY UPPER MANAGEMENT ON A ROUTINE BASIS FOR ANY ASSOCIATED TRENDS. WE VALUE YOUR ASSISTANCE IN PROVIDING US AN OPPORTUNITY TO EVALUATE THE REPORTED EVENT AS ALL INFORMATION REPORTED TO OUR COMPANY IS CRITICAL TO OUR CONTINUOUS IMPROVEMENT EFFORTS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS FIRED AND THE CLIPS WERE MALFORMED. THEY USED A SECOND LIKE DEVICE TO COMPLETE THE PROCEDURE. THE CLIPS WERE LEFT IN A CUP IN MATERIALS WITH A NOTE AND LIMITED INFORMATION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED HOWEVER THE CLIPS ARE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4C91H

    Patients

    Seq Age Sex Outcome Treatment
    1