BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 3233925 · Received July 18, 2013

    Report

    Report Number
    1527736-2013-00038
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. (B)(4). THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THERE ANY PROBLEMS WITH THE DEVICE DURING THE INITIAL PROCEDURE? WHAT DID THE CLIP FORMATION LOOK LIKE DURING THE INITIAL PROCEDURE? WAS THE SURGEON ABLE TO OBSERVE PROPER FORMATION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? WAS ANY TORQUE APPLIED TO THE DEVICE DURING USE? WAS THE DEVICE FIRED OVER A HARD OBJECT? HOW LONG POST OPERATIVE DID THE PATIENT PRESENT WITH SYMPTOMS OF A LEAK? DID THE ERCP IDENTIFY IF THE CLIPS WERE PRESENT? IF SO, WHAT DID THE CLIP FORMATION LOOK LIKE? WERE THERE ANY OTHER FACTORS THAT MAY HAVE LED TO THE LEAK? WHAT IS THE PATIENT¿S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? ARE THERE ANY X-RAYS, SCANS OR PICTURES AVAILABLE FOR ETHICON TO REVIEW? THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL DETAILS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THERE ANY PROBLEMS WITH THE DEVICE DURING THE INITIAL PROCEDURE? NOTED NOT TO CLOSED WHEN FIRED ON DUCT. WHAT DID THE CLIP FORMATION LOOK LIKE DURING THE INITIAL PROCEDURE? GAPS WHERE THE CLIPS DID NOT ADHERE AND CLOSE. WAS THE SURGEON ABLE TO OBSERVE PROPER FORMATION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? AFTER THE THEY DISCOVERED THAT THE CLIPS WERE NOT CLOSING, THEY STARTED TO CHECK TO BE SURE ALL OF THEM WERE CLOSED BEFORE CLOSING THE PT. WAS ANY TORQUE APPLIED TO THE DEVICE DURING USE? NO. WAS THE DEVICE FIRED OVER A HARD OBJECT? NO. HOW LONG POST OPERATIVE DID THE PATIENT PRESENT WITH SYMPTOMS OF A LEAK? 24-48 HOURS. DID THE ERCP IDENTIFY IF THE CLIPS WERE PRESENT? NO. IF SO, WHAT DID THE CLIP FORMATION LOOK LIKE? WERE THERE ANY OTHER FACTORS THAT MAY HAVE LED TO THE LEAK? NO.

    Description of Event or Problem · 1

    PLEASE REFERENCE THE ATTACHED MAUDE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334889 CLIP, IMPLANTABLE FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1