BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCANLAN MICRO CLAMP

    MDR report key: 1943583 · Received December 9, 2010

    Report

    Report Number
    2126670-2010-00002
    Event Type
    Other
    Date Received
    December 9, 2010
    Report Date
    December 7, 2010
    Manufacturer
    SCANLAN INTERNATIONAL, INC.
    Product Code
    DWS
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION FOUND THE JAWS ON THIS SEVEN YEAR OLD CLAMP WERE "REPAIRED" BY AN UNAUTHORIZED REPAIR FACILITY. THE UNAUTHORIZED FACILITY ALTERED THE SHAPE OF THE JAWS TO BE WIDER, CAUSING THE TIPS TO BE MORE TRAUMATIC. WE REPAIRED THIS CLAMP AND RESTORED IT TO OUR SPECIFICATIONS. RESTORED DEVICE RETURNED TO HEALTH FACILITY.

    Description of Event or Problem · 1

    "THE CLAMP DAMAGED THE AORTA WHEN SHE WENT TO CLAMP IT, EVEN AFTER REMOVING THE CLAMP, THERE WAS AN IMPRESSION OF THE SERRATED JAWS ON THE AORTA." "REPEAT SURGERY FOR AORTIC RECOARCTATION REQUIRING BYPASS AND CIRCULATORY ARREST. NO LONG TERM ISSUES." AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANLAN MICRO CLAMP MICRO CLAMP DWS SCANLAN INTERNATIONAL, INC. 3003-620 U41

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization