BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3895003 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04391
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 5, 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
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE SURGERY CONVERTED TO OPEN, OR WAS A SECOND SURGERY PERFORMED? SECOND SURGERY WAS PERFORMED. HOW MUCH BLOOD DID THE PATIENT LOST? WAS A TRANSFUSION REQUIRED? 1 UNIT (400CC) TRANSFUSION WAS DONE IN THE OPERATION ROOM AND 1 UNIT TRANSFUSION WAS DONE AFTER SURGERY. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? SEVERE CLIPS DONE CROSSED AFTER SHOOTING. CLIPS DO NOT CLOSED DISTAL PART PROPERLY. CROSSED CLIPS HAVE BEEN TAKEN BACK FROM ABDOMINAL. WAS THE CLIP FULLY ADVANCED INTO THE JAWS? YES. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? IN THE PATIENT. WHAT WERE THE PATIENT¿S PRE-EXISTING CONDITIONS? THE PATIENT WAS FINE. ANESTHESIA SYSTEM SCORE WAS 1. THERE WAS NO ANY CHRONIC ILLNESS. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? NO. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES, PATIENT IS FINE. WHAT IS THE PATIENT¿S CURRENT STATUS? THERE IS NO PROBLEM. IS THE SURGEON AN EXPERIENCED USER OF THIS PRODUCT? YES. IS THE SURGEON AN EXPERIENCED USER OF THIS PRODUCT? YES. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. SEVERE CLIPS DONE CROSSED AFTER SHOOTING ¿ 3 OR 5. IS THE SURGEON AN EXPERIENCED USER OF THIS PRODUCT? YES. IS THE SURGEON¿S STANDARD PRACTICE TO PLACE A DRAIN OR DID SOMETHING OCCUR THAT DROVE THE SURGEON TO PLACE THE DRAIN? YES, PLACING DRAIN IS STANDARD PRACTICE. MOREOVER, SALES REPRESENTATIVE EXPLAINED THAT HEMOGLOBIN RATE OF PATIENT WAS 13 PRE-OPERATION. THE RATE BECAME 9-10 POST-OPERATION. WAS A CHOLANGIOGRAM PERFORMED? UNKNOWN. WERE THERE ANY ISSUES WITH CLIP FORMATION DURING THE INITIAL PROCEDURE? NO. WERE THERE ANY ISSUES WITH FEEDING THE CLIP(S) DURING THE INITIAL PROCEDURE? NO. PLEASE CLARIFY WHAT IS MEANT BY ¿NOT CLOSE PROPERLY¿? CLIP COULD NOT CLOSE DISTAL PART. WAS THE CLIP NOT PROPERLY CLOSED MORE PROXIMALLY OR DISTALLY? DISTALLY. WERE THERE ISSUES NOTED WITH THE ALIGNMENT OF THE TWO CLIP LEGS? YES. CAN YOU PLEASE DESCRIBE THE SHAPE OF THE CLIP? PEAR SHAPED AND SCISSORED. WHAT IS THE PATIENT¿S CURRENT STATUS? PATIENT IS FINE. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? THE PATIENT HAS BEEN DISCHARGED FROM HOSPITAL. PATIENT IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIP WHICH WAS APPLIED TO CYSTIC ARTERY WAS NOT CLOSED PROPERLY AND WITH THE HELP OF THE DRAIN BLEEDING WAS SEEN JUST AFTER THE SURGERY. BECAUSE OF THE BLEEDING THEY HAD TO RETURN TO OPEN SURGERY AND CYSTIC ARTERY WAS CLOSED BY SUTURES. DEVICE WAS DISCARDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371355 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E38E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention