BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3052377 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01723
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? - THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? -- ARTERIA ILEOCOLICA. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? -- YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? -- NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? -- NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? -- NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? -- NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? -- YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, SCISSORING OCCURRED WHEN THE DEVICE WAS USED ON THE BLOOD VESSEL FOR LIGATION. THE INCIDENT OCCURRED IN TWO DEVICES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICES WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156254 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CP8U

    Patients

    Seq Age Sex Outcome Treatment
    1