BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2991604 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01107
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION PROVIDED: THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2013. ON (B)(6) AN ERCP IDENTIFIED A BILE LEAK AND A STENT WAS PLACED. THE PATIENT WAS DISCHARGED. ON (B)(6) THE PATIENT WAS READMITTED TO THE HOSPITAL TO HAVE THE STENT REPLACED. THE PATIENT WAS PUT ON LONGTERM ANTIBIOTICS AND DISCHARGED HOME ON (B)(6). THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) TO HAVE THE STENT REMOVED. THE PATIENT WAS DOING WELL AND WAS DISCHARGED HOME. THE CLIPS WILL NOT BE RELEASED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REQUESTED: 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? 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?

    Additional Manufacturer Narrative · 1

    (B)(4). CLIPS SAVED FROM THE EVENT SHOW THAT THE CLIPS ARE OPEN OR NOT FULLY CLOSED. PATIENT COMPLAINED OF CONTINUAL ABDOMINAL PAIN. AN ERCP WAS DONE AND A BILE LEAK WAS FOUND. PATIENT HAS A STENT PLACED.

    Description of Event or Problem · 1

    (B)(4).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94809 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1