BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2991576 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01105
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    March 27, 2024
    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
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REQUESTED: WERE THERE ANY PATIENT CONSEQUENCES BASED ON THE EVENT? HOW WAS THE CASE COMPLETED? DID CLIPS FALL INTO THE PATIENT? IF YES, HOW WERE THE CLIPS REMOVED? HOW WAS THE PATIENT IMPACTED? WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP DID NOT HOLD ON THE CYSTIC DUCT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. THE DEVICE WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95408 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown