BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2943974 · Received February 5, 2013

    Report

    Report Number
    3005075853-2013-00481
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 22, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING 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 TWO DEVICES PRESENTED ISSUES DURING THE INITIAL PROCEDURE AND THE THIRD DEVICE WORKED PROPERLY? HOW MANY OF THE DEVICES DID THE STICKINESS OCCUR WITH? PLEASE DEFINE WHAT IS MEANT BY ¿HANDLE IS STICKY¿. SLOW RETURN? WHAT DID CLIP FORMATION LOOK LIKE WITH ALL THE DEVICES? WAS THE SURGEON ABLE TO VISUALIZE PROPER OCCLUSION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? WAS A CHOLANGIOGRAM BEING USED? WAS THE DEVICE FIRED OVER AN EXISTING CLIP? HOW MANY CLIPS WERE FIRED DURING THE PROCEDURE? HOW MANY CLIPS WERE PLACED ON THE SPECIMEN SIDE AND THE PATIENT SIDE? HOW MANY HOURS OR DAYS POST OP DID THE PATIENT PRESENT WITH THE LEAK? WHAT ADDITIONAL PROCEDURE IS PLANNED TO ADDRESS THE LEAK? IF THE ADDITIONAL PROCEDURE HAS ALREADY TAKEN PLACE, WHAT DAY DID THIS OCCUR ON? HOW HAS IT BEEN DETERMINED THE LEAK IS RELATED TO THE CLIP APPLIER(S)? WHERE WAS THE LEAK IDENTIFIED? WERE CLIPS PRESENT IN THE SUSPECT AREA? IF SO, PLEASE DESCRIBE THE SHAPE OF THE CLIPS? WHAT IS THE PATIENT'S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? PLEASE DESCRIBE THE CHANGE IN THE PATIENT'S POST OPERATIVE CARE AS A RESULT OF THE EVENT. PATIENT'S SEX, AGE, AND WEIGHT? DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? WAS THIS AN EMERGENCY OR PLANNED CHOLE? HOW LONG HAS THIS SURGEON BEEN USING THIS DEVICE? ARE YOU AWARE OF THE LAST TIME THE SURGEON OR STAFF WAS IN-SERVICED FOR THIS DEVICE? ARE ANY PATIENT SCANS AVAILABLE FOR ETHICON TO REVIEW?

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT LOAD THE CLIPS INTO THE JAWS PROPERLY. THE FIRING HANDLE DID NOT REBOUND PROPERLY. THE HANDLE WAS "STICKY" AND DID NOT RETURN TO ITS PROPER POSITION AFTER FIRING. THIS CAUSED THE CLIPS TO BE IMPROPERLY LOADED. CLIPS WOULD EITHER FIRE OUT OF THE JAWS OR LOAD SIDEWAYS. THERE WERE A TOTAL OF THREE CLIP APPLIERS USED IN THIS CASE. THE THIRD DEVICE WORKED WELL ENOUGH TO COMPLETE THE CASE BUT NOW THE PATIENT HAS A LEAK IN THE DUCT AND HAS TO HAVE ADDITIONAL SURGERY TO CORRECT THE PROBLEM. TO DATE THE SURGERY HAS NOT BEEN PERFORMED BUT THE PATIENT IS STILL IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48623 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4A54Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R