BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3080586 · Received April 26, 2013

    Report

    Report Number
    3005075853-2013-01986
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 3, 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). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. THE JAWS WERE FOUND PROPERLY ALIGNED. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE EJECTED AND THEN, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE FOUND CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHY WAS THE CLIP NOT RETRIEVED FROM THE PATIENT? BECAUSE THE CLIP WAS CONFIRMED ON X-RAY AFTER CLOSING THE ABDOMEN. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? -- CHOLECYST. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? -- NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? YES, OUT OF THE PATIENT. THE CLIP EJECTED. WHAT WERE THE INDICATIONS FOR SURGERY? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT WAS FOUND? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE CLIP WAS NOT FED INTO THE JAWS AT THE 2ND FIRING. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS FIRED, THE CLIP EJECTED. THE 2ND CLIP WHICH WAS SUPPOSED TO BE FED INTO THE JAWS EJECTED INSIDE THE PATIENT AND IT REMAINED INSIDE THE PATIENT. THE DEVICE WAS FIRED PROPERLY WITHOUT AN UNEXPECTED RESISTANCE AND AN UNEXPECTED NOISE IN GRASPING THE TRIGGER AT THE 1ST FIRING. 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
    182093 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1