BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2032059 · Received March 28, 2011

    Report

    Report Number
    3005075853-2011-01231
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: A PICTURE OF THE CLIPS WAS PROVIDED AND SENT TO ETHICON ENDO-SURGERY'S FIELD QUALITY ENGINEER FOR REVIEW: "SINCE THE CLIP APPLIERS WERE NOT RETURNED FOR ANALYSIS, THE OBSERVATIONS ARE MY OPINION AND DESCRIBE CONDITIONS THAT CAN CREATE CLIPS OF SIMILAR FORM AS THOSE IN THE PHOTOGRAPH." OBSERVATION 1: THE CLIP IN THE PICTURE THAT APPEARS TO HAVE A SLIGHT LEG MISALIGNMENT MAY BE THE RESULT OF ROTATIONAL FORCE (TORQUING) OF THE JAWS AND /OR MOVEMENT DURING FIRING. OBSERVATION 2: THE CLIP WITH THE TEAR DROP SHAPE MAY HAVE RESULTED FROM FIRING TO RAPIDLY NOT ALLOWING THE FIRST CLIP TO CLEAR BEFORE THE SECOND CLIP TRIES TO ADVANCE. IN THIS CASE, THE SECOND CLIP DOES NOT ADVANCE INTO THE JAWS COMPLETELY. HENCE THE LOOP END OF THE CLIP DOES NOT GET COMPRESSED. OBSERVATION 3: THE CLIP THAT APPEARS TO BE FORMED BUT WITH THE CLIP LEG TIPS NOT TOUCHING MAY BE THE RESULT OF THE STRUCTURE TO BE LIGATED BEING PLACED IN THE FRONT HALF OF THE JAWS. HOWEVER, THE CLIP DOES NOT APPEAR TO BE MALFORMED, SO I AM ASSUMING THAT CLIP SECURITY MAY HAVE BEEN THE CONCERN. HENCE TO FAR FORWARD IN THE JAWS. OBSERVATION 4: THE REMAINING 3 CLIPS WITH THE LEG TIPS TOUCHING AND A SLIGHT ELLIPTICAL SHAPE AT THE CLIP APEX, IN MY OPINION ARE NOT MALFORMED. CONSIDERING THE POTENTIAL SIZE OF THE CYSTIC DUCT AND ARTERY, THIS MAY HAVE BEEN A CASE WHERE THE OVERLOAD MECHANISM DISENGAGED TO PROTECT THE JAWS. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP APPLIER WAS DEPLOYING UNFORMED AND SCISSORED CLIPS, OR CLIPS THAT WOULD NOT STAY ON THE STRUCTURE TO BE LIGATED. THE SURGEON OPENED ANOTHER DEVICE WHICH DID THE SAME THING, BUT ENOUGH PROPERLY FORMED CLIPS WERE DEPLOYED EVENTUALLY TO BE ABLE TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4UC8C

    Patients

    Seq Age Sex Outcome Treatment
    1