BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UCLIP ANASTOMOTIC DEVICE

    MDR report key: 1658643 · Received April 7, 2010

    Report

    Report Number
    2135394-2010-00006
    Event Type
    Injury
    Date Received
    April 7, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 11, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    FZP
    PMA / PMN Number
    K031623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION METHOD: DEVICE HISTORY REVIEWED. NO DEVICE RETURNED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. NO DEVICE RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WILL BE RETURNED FOR ANALYSIS. DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. SHOULD ADDITIONAL INFORMATION BE PROVIDED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT DURING A BARIATRIC PROCEDURE, THE NEEDLE BECAME DISLODGED FROM THE UCLIP RELEASE ASSEMBLY AS THE PHYSICIAN WAS EXTRACTING THE ASSEMBLY THROUGH THE PORT AND DROPPED INTO THE ABDOMINAL CAVITY. X-RAY WAS CALLED INTO THE OPERATING ROOM, BUT THE NEEDLE COULD NOT BE LOCATED. AN ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE INTRA-OPERATIVELY THROUGH A MINI-LAPAROSCOPY, BUT WAS UNSUCCESSFUL. ON FOLLOW-UP IMAGING, THE NEEDLE WAS FOUND, AND THE NEEDLE WAS REMOVED LAPAROSCOPICALLY THE FOLLOWING DAY. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCLIP ANASTOMOTIC DEVICE FZP MEDTRONIC PERFUSION SYSTEMS B120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention