BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3170302 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03022
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 21, 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 Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. 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. PLEASE SPECIFY WHAT IS MEANT BY ¿THE DEVICE DID NOT FIRE¿. DID THE CLIP ADVANCE INTO THE JAWS? WAS THE CLIP IN THE JAWS BUT WOULD NOT DEPLOY? OR WAS THE DEVICE LOCKED OUT? CAN THE SURGEON DESCRIBE THE CLIP FORMATION ON THE CLIP THAT DID FIRE SUCCESSFULLY? WAS AN ERCP PERFORMED? IF ONLY THREE ER320 CLIPS WERE USED, WHAT OTHER LIGATING DEVICES WERE USED? ARE THERE ANY PICTURES OR VIDEOS AVAILABLE FOR ETHICON TO REVIEW? WHAT IS THE PATIENT¿S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? WILL THE DEVICE BE MADE AVAILABLE AT A LATER DATE? 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). MEDICAL RECORDS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2013 AND WAS DISCHARGED THE SAME DAY. DURING THE PROCEDURE, THE DEVICE WAS FIRED THREE TIMES. THE FIRST TWO FIRING THE DEVICE DID NOT FIRE. THE THIRD ONE THE CLIP DEPLOYED AND EVERYTHING APPEARED OKAY. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. TWO DAYS POST-OP, (B)(6) 2013, THE PATIENT RETURNED WITH POST ABSCESS BILE LEAK. THEY DID AN INTRA PERITONEAL ABSCESS ASPIRATION. PATIENT DID NOT HAVE TO GO BACK TO SURGERY, THEY WERE ABLE TO CORRECT WITH IR. THESE ARE ALL THE DETAILS KNOWN. THE DEVICE HAS BEEN SEQUESTERED AT THE ACCOUNT AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271673 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention