BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3070142 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01870
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 27, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHICH FIRING OF THE DEVICE DID THE PROBLEM OCCUR (1ST, 2ND, ETC)? FIRST. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC CANAL. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHEN PRESSING THE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. DID ANY CLIPS FALL INTO THE PATIENT? YES. IF YES, WERE THEY RETRIEVED? YES. WAS THE DEVICE FIRED AFTER THIS INCIDENT, IN OR OUT OF THE PATIENT? NO. WHAT WERE THE PATIENT INDICATIONS FOR SURGERY? UNK. WHAT WAS FOUND DURING SURGERY? UNK. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. DID SOMEONE OTHER THAN THE PRIMARY SURGEON FIRE THE DEVICE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLYCESTECTOMY PROCEDURE, ON THE FIRST FIRING OVER THE CYSTIC CANAL THE CLIP DEPLOYED WITH CROSSED LEGS. THE CLIP WAS REMOVED AND ANOTHER CLIP WAS DEPLOYED, BUT IT FELL INTO THE PATIENT. AN ATTEMPT TO APPLY A 3RD CLIP RESULTED IN THE CLIP FALLING INTO THE PATIENT AS WELL. A RESUABLE CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE. FIVE MINUTE TIME DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171978 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK J4CT5R

    Patients

    Seq Age Sex Outcome Treatment
    1