BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3790599 · Received May 5, 2014

    Report

    Report Number
    3005075853-2014-03037
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CONFIRM IF ANY TRAINING WAS CONDUCTED PRIOR TO THE USE OF THE LIGAMAX DEVICE? DID THE SURGEON FIRE THE DEVICE IN A 1 STAGE OR 2 STAGE PROCESS? WAS SCISSORING OBSERVED IN THE INITIAL PROCEDURE? IF SO, WHAT WAS DONE TO ADDRESS THE SCISSORED CLIPS? HOW WAS THE LEAK DETECTED? HOW LONG POST OP DID THE PATIENT PRESENT WITH THE LEAK? WAS THERE A SECOND PROCEDURE? IF SO, WHAT WAS NOTED? WHAT DID THE CLIP FORMATION LOOK LIKE? WAS AN ERCP PERFORMED? DURING THE RE-OP DID THEY NOTICE SCISSORED CLIPS ON THE STRUCTURE OR OFF THE STRUCTURE? ARE THERE ANY PHOTOGRAPHS OR VIDEO AVAILABLE? HAS THE PATIENT HAD A FULL RECOVERY?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DOCTOR CLAIMED THAT THE CLIPS WAS SCISSORING, THAT¿S WHY THERE WAS A LEAKING AFTERWARDS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268949 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1