BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3080685 · Received April 26, 2013

    Report

    Report Number
    3005075853-2013-01993
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 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 Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHY DID THE CLIPS FALL INTO THE PATIENT, IF DEVICE JAMMED? - THE CLIP DID NOT FALL INTO THE PATIENT. DID THE DEVICE DROP/EJECT CLIPS? YES. DID CLIPS FALL OFF OF THE STRUCTURE? - YES. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? - AT THE 4TH OR THE 5TH FIRING. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? - BLOOD VESSEL. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? - THE INFORMATION WAS NOT PROVIDED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, JAMMING OCCURRED. NO CLIPS WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182562 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1