BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4123449 · Received September 26, 2014

    Report

    Report Number
    3005075853-2014-06702
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 15, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH A CLIP IN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO INSPECT THE JAWS AND THEY WERE FOUND TO BE IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED AND FED AND FORMED FOUR SCISSORED CLIPS, AND THEN THREE CONFORMING CLIPS WERE FORMED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. ALTHOUGH IT IS NOT POSSIBLE TO CONCLUDE HOW THE CIRCUMSTANCES OCCURRED, IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT AN INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS. IN ADDITION AS PER THE INSTRUCTIONS FOR USE ¿DO NOT EXCESSIVELY TWIST OR TORQUE THE INSTRUMENT JAWS WHEN POSITIONING THE INSTRUMENT ON A VESSEL AND FIRING. EXCESSIVE TWISTING OR TORQUING MAY RESULT IN CLIP MALFORMATION¿. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE REP SAID THAT AFTER THE PROCEDURE HE WATCHED THE SURGEON USE THE DEVICE; THE JAWS WERE TORQUED TO ONE SIDE WHILE APPLYING THE CLIPS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THERE ANY BLEEDING OR LEAK THAT OCCURRED WHEN CLIPS WOULD NOT HOLD ON VESSELS? IF BLEEDING, PLEASE QUANTIFY AMOUNT OF BLEEDING? WERE ANY BLOOD PRODUCTS GIVEN? WAS THERE ANY CHANGE TO PROCEDURE OR POST-OP PATIENT CARE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT FORM CORRECTLY AND FELL OFF OF THE STRUCTURES WHEN THE SURGEON WENT TO APPLY THE CLIPS TO THE CYSTIC DUCT AND ARTERY. THE SEVERAL CLIPS IN A ROW WERE NOT FORMED, THE CLIPS HAD STRAIGHT LEGS, APPEARED LIKE THEY ARE WHEN IN THE DEVICE BEFORE FIRING. THE CASE WAS COMPLETED WITH THIS SAME DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600261 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L90E9K

    Patients

    Seq Age Sex Outcome Treatment
    1