BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2943761 · Received February 5, 2013

    Report

    Report Number
    3005075853-2013-00475
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 18, 2013
    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
    LA, US
    Reporter Occupation
    OTHER

    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. DID THE SURGEON EXPERIENCE ANY PROBLEMS WITH THE DEVICE DURING THE INITIAL PROCEDURE? WAS A CHOLANGIOGRAM BEING USED? WAS THE DEVICE FIRED OVER AN EXISTING CLIP? WAS THE SURGEON ABLE TO VISUALIZE PROPER OCCLUSION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? HOW MANY CLIPS WERE FIRED DURING THE PROCEDURE? WHERE WAS THE LEAK COMING FROM? WHERE WERE THE SCISSORED CLIPS LOCATED? WHAT WAS DONE TO REPAIR THE LEAK? WHAT IS THE PATIENT'S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? PATIENT'S SEX, AGE, AND WEIGHT? DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? WAS THIS AN EMERGENCY OPERATING ROOM PLANNED CHOLE? HOW LONG HAS THIS SURGEON BEEN USING THIS DEVICE? ARE THERE ANY X-RAYS AVAILABLE? HAVE THERE BEEN ANY TECHNIQUE CHANGES? ARE YOU AWARE OF THE LAST TIME THE SURGEON OR STAFF WAS IN-SERVICED FOR THIS DEVICE? 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: DID THE SURGEON EXPERIENCE ANY PROBLEMS WITH THE DEVICE DURING THE INITIAL PROCEDURE? YES. WAS A CHOLANGIOGRAM BEING USED? NO. WAS THE DEVICE FIRED OVER AN EXISTING CLIP? NO. WAS THE SURGEON ABLE TO VISUALIZE PROPER OCCLUSION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? YES. HOW MANY CLIPS WERE FIRED DURING THE PROCEDURE? THE 7. 3 PATIENT SIDE. WHERE WAS THE LEAK COMING FROM? CYSTIC ARTERY. WHERE WERE THE SCISSORED CLIPS LOCATED? CYSTIC ARTERY. WHAT WAS DONE TO REPAIR THE LEAK? PATIENT BROUGHT BACK TO SURGERY AND PLACED MORE CLIPS WITH ER320. WHAT IS THE PATIENT'S CURRENT STATUS? HEALTHY. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. PATIENT'S SEX, AGE, AND WEIGHT? FEMALE, (B)(6). DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? NO. WAS THIS AN EMERGENCY OR PLANNED CHOLE? PLANNED. HOW LONG HAS THIS SURGEON BEEN USING THIS DEVICE? FIFTEEN YEARS. ARE THERE ANY X-RAYS AVAILABLE? NO. HAVE THERE BEEN ANY TECHNIQUE CHANGES? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE CASE WENT WELL. SOMETIME AFTER THE PROCEDURE THERE WAS A POST OP LEAK. IT IS UNKNOWN HOW THE LEAK WAS DETECTED. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM AND IT WAS FOUND THAT THERE WERE SCISSORED CLIPS PRESENT. IT IS UNKNOWN HOW THE LEAK WAS REPAIRED. THE PATIENT IS CURRENTLY STABLE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47444 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention