BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 3885242 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04163
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE ER420 DEVICE WAS RETURNED WITH A MALFORMED CLIP JAMMED IN JAWS; THIS CONDITION PREVENTED THE DEVICE FROM PROPER FEEDING OF THE CLIPS. THE JAWS WERE NOTED TO BE PROPERLY ALIGNED. THE JAMMED CLIP WAS REMOVED FROM THE JAWS AND IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT; THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING 12 CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE RETURNED CONDITION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE ER420 DEVICE WAS RETURNED WITH A MALFORMED CLIP JAMMED IN JAWS; THIS CONDITION PREVENTED THE DEVICE FROM PROPER FEEDING OF THE CLIPS. THE JAWS WERE NOTED TO BE PROPERLY ALIGNED. THE JAMMED CLIP WAS REMOVED FROM THE JAWS AND IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT; THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING 12 CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE RETURNED CONDITION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THAT THE SURGEON STATED THAT THE CLIPS WERE NOT HOLDING ONTO THE TISSUE FROM THE INITIAL FIRING. HE WAS USING A CHOLANGIOGRAM. THE DEVICE WAS DIFFICULT TO FIRE BUT MADE NO NOISES. THE SURGEON WAS FIRING THE DEVICE. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE IS RETURNING FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THAT THE SURGEON STATED THAT THE CLIPS WERE NOT HOLDING ONTO THE TISSUE FROM THE INITIAL FIRING. HE WAS USING A CHOLANGIOGRAM. THE DEVICE WAS DIFFICULT TO FIRE BUT MADE NO NOISES. THE SURGEON WAS FIRING THE DEVICE. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE IS RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361097 LIGACLIP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CE36

    Patients

    Seq Age Sex Outcome Treatment
    1