BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3073290 · Received April 23, 2013

    Report

    Report Number
    3005075853-2013-01932
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 21, 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 ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: PLEASE CLARIFY WHAT IS MEANT BY THE CLIP WAS NOT FED INTO THE JAWS PROPERLY AND THE CLIP WAS NOT FIRED PROPERLY-- THE CLIP DID NOT FULLY ADVANCE INTO THE JAWS AND A SCISSORING OCCURRED. DID THE CLIP FEED INTO THE JAWS SIDEWAYS? -- NO. DID THE CLIP FEED SLOWLY INTO THE JAWS? -- NO. DID MORE THAN ONE CLIP FEED INTO THE JAWS AT ONCE? -- NO. DID THE CLIP DEPLOY FROM THE JAWS WHEN FIRED? -- YES. DID THE CLIP FULLY ADVANCE INTO THE JAWS PRIOR TO FIRING? -- NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? A LITTLE BIT. WERE ANY UNEXPECTED NOISES HEARD? -- NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? -- NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? -- YES.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE WAS FIRED WITH A LITTLE BIT TENSION AT THE 2ND FIRING. AFTER THAT, THE CLIP WAS NOT FED INTO THE JAWS PROPERLY AND THE CLIP WAS NOT FIRED PROPERLY AT THE 3RD FIRING WHEN THE DEVICE WAS USED ON THE CYSTIC DUCT. 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
    174594 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1