BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3112288 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02317
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? LAP CHOLE. PLEASE PROVIDE THE LOT NUMBER OF THE DEVICE. ASKU. WHAT WAS THE SURGERY DATE OF THE PROCEDURE? (B)(6) 2013. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ASKU. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WERE THERE ANY FEEDING ISSUES EXPERIENCED WITH THE DEVICE? YES. CLIP SCISSORED ACROSS THE CYSTIC ON THE DUCT THE SURGEON CLAIMED HE MUST REMOVE THE DEVICE FROM THE PATIENT AND DRY FIRE TO CLEAR THE DEVICE DUE TO SLOW FEEDING ISSUES. WAS THE SURGEON ABLE TO VISUALIZE A CLIP FED INTO THE JAWS PRIOR TO FIRING THE DEVICE? ASKU. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? SOME BUT NOT EXTREME. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ASKU. WHAT WERE THE INDICATIONS FOR SURGERY? GALL BLADDER DISEASE. WHAT WAS FOUND? DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? NO. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO. HOW WAS THE CASE COMPLETED? MANUAL CLIP APPLIER THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RECEIVED WITH THE LOCKOUT MECHANISM NON FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN CASE, THE CLIPS CRISS-CROSSED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. THIS IS ALL THE INFORMATION THAT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213404 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1