BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2904871 · Received January 9, 2013

    Report

    Report Number
    3005075853-2013-00160
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    July 30, 2012
    Report Date
    December 14, 2012
    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
    CA
    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: THE PATIENT WAS RE-OPERATED ON A FEW DAYS AFTER TO STOP THE BLEEDING. THE SURGEON SAW THAT CLIPS WERE NOT THERE ANYMORE WHEN HE REOPENED THE PATIENT. HE THEN THOUGHT THAT THE CAUSE OF THE BLEEDING WAS THE CLIP APPLIER. THE PATIENT WAS STABLE FOLLOWING THIS PROCEDURE. ON WHICH FIRING OF THE DEVICE DID THE PROBLEM OCCUR (1ST, 2ND, ETC)? UNKNOWN. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC ARTERY. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? (IF APPLICABLE FOR THE REPORTED DEVICE) YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE AT THE TIME OF FIRING? UNK. WAS ANY UNEXPECTED RESISTANCE FELT WHEN PRESSING THE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. DID ANY CLIPS FALL INTO THE PATIENT? YES. IF YES, WERE THEY RETRIEVED? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT, IN OR OUT OF THE PATIENT? NO. WHAT WERE THE PATIENT INDICATIONS FOR SURGERY? LAP CHOLE. WHAT WAS FOUND DURING SURGERY? STONES. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. DID SOMEONE OTHER THAN THE PRIMARY SURGEON FIRE THE DEVICE? NO. WAS THERE RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? YES. ATTEMPTS ARE ALSO BEING MADE TO OBTAIN ADDITIONAL INFORMATION BELOW. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. HOW MANY CLIPS WERE APPLIED DURING THE INITIAL PROCEDURE? DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? WAS THE DEVICE FIRED ON A HARD OBJECT (E.G. A CLIP)? DURING THE REOPERATION THE SURGEON MENTIONED THE CLIPS WERE NOT PRESENT ON THE CYSTIC ARTERY; WERE THE CLIPS LOCATED IN THE PATIENT¿S ABDOMEN? IF SO, PLEASE DESCRIBE THE SHAPE OF THE CLIPS. DURING THE REOPERATION WAS THE SURGEON ABLE TO OBSERVE PROPERLY FORMED CLIPS ON THE CYSTIC DUCT? 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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MANY CLIPS WERE APPLIED DURING THE INITIAL PROCEDURE? 3 OR 4. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? NO. WAS THE DEVICE FIRED ON A HARD OBJECT (E.G. A CLIP)? NO. DURING THE REOPERATION THE SURGEON MENTIONED THE CLIPS WERE NOT PRESENT ON THE CYSTIC ARTERY; WERE THE CLIPS LOCATED IN THE PATIENT'S ABDOMEN? YES, THE CLIP WERE MALFORMED AND REMOVED FROM THE PATIENT ABDOMEN. IF SO, PLEASE DESCRIBE THE SHAPE OF THE CLIPS. "Y" SHAPE. DURING THE REOPERATION WAS THE SURGEON ABLE TO OBSERVE PROPERLY FORMED CLIPS ON THE CYSTIC DUCT? NO. WHAT STEPS WERE TAKEN TO CONTROL THE BLEEDING? REOPERATION. USED A REUSABLE SINGLE CLIP APPLIER TO STOP THE BLEEDING. THE PATIENTS IS DOING WELL. NO PERMANENT INJURY OR DISABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE FUNCTIONED WITHOUT NOTED PROBLEMS DURING THE CASE. A FEW DAYS POST-OPERATIVELY THE PATIENT HAD BLEEDING WHICH WAS LIFE-THREATENING. IT IS UNKNOWN HOW THE BLEEDING WAS ADDRESSED OR THE CONDITION OF THE PATIENT AFTER THE POST OPERATIVE INCIDENT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10623 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention