BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2970126 · Received February 20, 2013

    Report

    Report Number
    3005075853-2013-00771
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 1, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING INFORMATION: WERE THE CLIPS NOT HOLDING DURING THE INITIAL PROCEDURE? IF SO, CAN THE SURGEON DESCRIBE THE SHAPE OF THE CLIPS? WAS THE DEVICE FIRED OVER AN EXISTING CLIP? DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWIST THE DEVICE? WAS THE DEVICE USED FOR A CHOLANGIOGRAM? WAS THE SURGEON ABLE TO VISUALIZE PROPER OCCLUSION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? HOW MANY CLIPS WERE FIRED ON THE PATIENT SIDE AND SPECIMEN SIDE? HOW MANY HOURS OR DAYS POST OP WAS THE PATIENT RETURNED TO THE OPERATING ROOM? WHAT WAS DONE TO REPAIR THE LEAK? WHAT WAS OBSERVED DURING THE REOPERATION? WERE CLIPS FOUND ON THE BILE DUCT OR WERE NO CLIPS OBSERVED? CAN THE SURGEON DESCRIBE THE SHAPE OF THE CLIPS (SEE ATTACHED PHOTO)? WAS THIS AN EMERGENCY OR PLANNED CHOLECYSTECTOMY? WAS THIS A TYPICAL CASE? DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? PATIENT'S ANATOMY PRESENT WITH ANY CHALLENGES FOR THE CASE? WHAT IS THE PATIENT'S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? PATIENT'S SEX, AGE, AND WEIGHT? HOW LONG HAS THIS SURGEON BEEN USING THIS DEVICE? ARE THERE ANY X-RAYS, VIDEOS, OR PICTURES AVAILABLE FOR ETHICON REVIEW? THE ETHICON SALES REPRESENTATIVE SPOKE WITH THE SURGEON SEVERAL TIMES AND HE ASSURES THAT HE IS NOT TWISTING OR TORQUING THE DEVICE. HE HAS BEEN USING THE PRODUCT FOR 14 YEARS. HE SAYS THE CLIPS DON'T STAY ON OR THEY SCISSOR. THIS IS ALL THE INFORMATION HE WOULD PROVIDE REGARDING THE EVENT. ATTEMPTS ARE BEING MADE BY ETHICON TO COORDINATE A CONVERSATION WITH THE SURGEON, BUT HE HAS NOT AGREED TO MEET. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. NO CLIPS GAP WAS OBSERVED DURING TESTING. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THERE WERE THREE OR FOUR CLIPS THAT WOULD NOT HOLDING. IT IS UNKNOWN IF THE CLIPS FELL INTO THE PATIENT. POST OP ON AN UNKNOWN DATE THE PATIENT WAS RETURNED TO THE OPERATING ROOM DUE TO A POST OP LEAK. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73913 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention