BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGATING CLIPS

    MDR report key: 3142941 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02753
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING 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. WHERE THERE ANY CLIP FORMATION ISSUES IDENTIFIED IN THE INITIAL PROCEDURE? HOW MANY CLIPS WERE USED IN THE INITIAL PROCEDURE? WHAT WAS THE OBSERVED APPEARANCE OF THE CLIPS IN THE SECOND (ERCP) PROCEDURE? WHAT IS THE CURRENT PATIENT CONDITION? 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2013 AND RETURNED TO THEATRE ON (B)(6) 2013, FOLLOWING INCREASE IN ABDOMINAL PAIN AND DRAINAGE OF BIL. PATIENT TRANSFERRED TO ANOTHER HOSPITAL FOR ERCP ON (B)(6) 2013, FOR ONGOING BILE LEAK. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243535 ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGATING CLIPS CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention