BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3583772 · Received January 21, 2014

    Report

    Report Number
    3005075853-2014-00518
    Event Type
    Injury
    Date Received
    January 21, 2014
    Date of Event
    September 24, 2012
    Report Date
    January 8, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE PATIENT COMPLAINED OF ONGOING ABDOMINAL PAIN AFTER LAPAROSCOPIC CHOLECYSTECTOMY. INITIALLY WE MADE AN ULTRASOUND OF THE ABDOMEN (3 DAY) WHICH DID NOT SHOW AN Y INTRA­ ABDOMINAL FLUID COLLECTION. HOWEVER, THE PATIENT CONTINUED TO COMPLAIN OF SEVERE PAIN. THE GASTRO-ENTEROLOGIST WHO WAS: FAMILIAR WITH THE PATIENT AND HER PREVIOUS MEDICAL HISTORY WAS CONSULTED AND HE ADVISED AN ERCP. DURING ERCP BILE JEALCAGE WAS CONFIRMED AND ME ORIGINAL CLIPS SEEMED DISPLACED. THE MXT DAY DUE TO ONGOING PAIN A RE-LAPAROSCOPY WAS PERFORMED AND 500 ML OF BILE \OJ3S REMOVED. BILE LEAKAGE WAS NOTED 4 DAYS AFTER THE ORIGINAL SURGERY BY ERCP. NO CHOLANGIOGRAM WAS PERFORMED DURING THE INITIAL PROC-EDURE. ROUTINE CHOLANGIOGRAM IS NOT ROUTINE IN OUR HOSPITAL). NO PROBLEMS WITH THE LIGACLIP DEVICE WERE NOTED DURING THE PROCEDURE. THE INTERNAL REVIEW WAS BASED UPON THE PERIOPERATIVE PHOTOS WHICH WE CAN SEND YOU. FURTHER INTERNAL REVIEW BASED ON THE COMPLAINTS OF THE PATIENTS ARE AVAILABLE. THE BILE LEAKAGE WAS TREATED BY STENT PLACEMENT DURING THE E-RCP AND BILE REMOVAL BY RE-LAPAROSCOPY THE NEXT DAY. ERCP SHOWED BILE LEAKAGE AND NO CLIPS AT THE CYSTIC DUCT STUMP. THE SECOND CLIPS SEEMS PERHAPS 001 FONNED AS IDEALLY HOPED ON THE PERIOPERATIVE PHOTO. HOWEVER. DURING THE. INITIATE PROCEDURE THE CLIP POSITIONS SUPPOSED ADEQUATE SEALING OF THE CYSTIC DUCT. THE SURGEON HIMSELF. NO ANATOMICAL ABNORMALITIES OF THE DUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CONFIRM THAT BLADDER LEAKAGE IS TRULY GALLBLADDER/BILE LEAKAGE? WHEN WAS BLADDER LEAKAGE NOTED? HOW WAS THE BLADDER LEAKAGE IDENTIFIED? WAS A CHOLANGIOGRAM PERFORMED IN THE ORIGINAL PROCEDURE? WERE THERE ANY ISSUES NOTED IN REGARDS TO DEVICE PERFORMANCE IN THE INITIAL PROCEDURE TO INCLUDE DIFFICULTIES WITH CLIP FEEDING OR FORMING? WOULD THE RESULTS OF THE INTERNAL INVESTIGATION BE AVAILABLE FOR ETHICON ENGINEERING REVIEW? ARE THERE ARE ANY VIDEOS OR PHOTOS OF THE ORIGINAL PROCEDURE AVAILABLE? WHAT WAS DONE TO ADDRESS THE BLADDER LEAKAGE? WAS THERE AN ADDITIONAL SURGICAL PROCEDURE? DURING THE INTERNAL INVESTIGATION WAS THERE ANY EVIDENCE OF CLIPS FALLING OFF OR CLIP MALFORMATION IDENTIFIED? WERE THERE ANY FEEDING OR FORMING ISSUES NOTED IN THE INITIAL PROCEDURE? WHO WAS ACTUALLY FIRING THE DEVICE? WAS THIS A TRAINING FACILITY? WAS THERE ANYTHING UNUSUAL NOTED ABOUT THE DUCT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2012. AFTER THE SURGERY, A BLADDER LEAKAGE WAS NOTICED LIKELY CAUSED BY LOOSENING OF THE CLIPS POST OPERATIVE. CURRENTLY THE PATIENT STILL HAS HEALTH ISSUES AND REVALIDATES. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48077 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention