BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEBAKEY TANGENT OCCL CLMP 10

    MDR report key: 1860121 · Received September 21, 2010

    Report

    Report Number
    2430952-2010-00050
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS, INC.
    Product Code
    DXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT "WHEN THE JAWS ARE CLOSED, THE TIPS AND BOTTOMS SHOULD BE CLOSED AT FIRST. HOWEVER, WHEN THE DOCTOR CLOSED THE JAW COMPLETELY, THE TIPS AND BOTTOM PARTS ARE OPENED. SO THE VASCULA (VESSEL?) MAY SLIP FROM THE TIP OR BOTTOM. IT IS DANGEROUS IN OPERATIVE." THE CUSTOMER INDICATES DEVICE WAS IN CONTACT WITH A PT AND THAT THERE WAS AN INJURY. ON (B)(6) 2010, THE DEALER REPORTS THAT DURING A LIVER TRANSPLANT THE SURGEON WAS DOING THE PROCEDURE OF CLAMPING AND CUTTING THE VESSELS OF THE PORTA HEPATIS AT WHICH TIME THE ENDO-MEMBRANE OF THE VESSELS WERE INJURED. THIS CAUSED THROMBOSIS IN THE VESSELS AND THE FAILURE OF THE TRANSPLANT. THERE WAS NO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEBAKEY TANGENT OCCL CLMP 10 CARDIOVASCULAR CLAMPS 1 DXC J. JAMNER SURGICAL INSTRUMENTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R