BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3973532 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05416
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 23, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS OF THE ER320 DEVICE FOUND THAT IT WAS RECEIVED WITH A CLIP WITHIN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO MEASURE JAWS WIDTH AND THEY WERE FOUND TO BE YIELDED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, SEVEN CLIPS WERE FED AND FORMED AS INTENDED. 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 IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL. 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: CALLED CUSTOMER WHO REPORTED DEVICE DID NOT FEED CLIPS ON FIRST ATTEMPTED FIRING. CUSTOMER ALSO SAID UNKNOWN IF ANY LEAK OR BLEEDING WHEN CLIP CAME OFF OF TISSUE AS SHE WAS NOT IN CASE, BUT NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ON THE FIRST FIRING, THE CLIP DID NOT COME DOWN FROM THE DEVICE (THE CLIP DID NOT FEED). ON THE SECOND FIRING, THE CLIPS DID NOT STAY ON TISSUE. IT IS UNKNOWN IF ANY LEAK OR BLEEDING OCCURRED. IT WAS NOT KNOWN HOW THE STAPLES APPEARED OR HOW THEY WERE SHAPED. A CHOLANGIOGRAM WAS NOT DONE ON THIS PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. NO PATIENT CONSEQUENCES WERE REPORTED. ALL KNOWN INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450543 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EM7V

    Patients

    Seq Age Sex Outcome Treatment
    1