BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPOLAR TRIGGER-FLEX PROBE

    MDR report key: 1277653 · Received November 21, 2008

    Report

    Report Number
    2428235-2008-00013
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K003126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED YET. WE WILL FOLLOW-UP ON THIS MDR, ONCE PRODUCT IS RECEIVED. THE COMPANY HAS EVALUATED PRODUCT FROM PRODUCTION LOT IN QUESTION ALONG WITH ADDITIONAL LOTS OF TRIGGERFLEX, CONTAINING ELECTRODE TIPS FROM EACH OF OUR SUPPLIERS. OUR TESTING DID NOT REPLICATE THE FAILURE MODE DURING NORMAL OPERATING CONDITIONS. HOWEVER, OUR TESTING WAS ABLE TO REPLICATE THE FAILURE MODE UNDER EXTREME CONDITIONS, BUT ONLY FOR TIPS MANUFACTURED BY ONE OF OUR SUPPLIERS. THIS IS THE SAME SUPPLIER THAT MANUFACTURED THE TIP, WHICH FAILED IN SURGERY. THE COMPANY HAS MADE THE DECISION TO RECALL ALL PRODUCT LOTS CONTAINING ELECTRODE TIPS FROM THIS SUPPLIER.

    Description of Event or Problem · 1

    REP INFORMED US THAT A SURGICAL CENTER REPORTED A PROBLEM WITH A TRIGGERFLEX DTF-40. DURING THE PROCEDURE, THE HAND PIECE STUCK IN THE EXTENDED POSITION. AS THE DEVICE WAS BEING REMOVED, A PIECE OF MATERIAL SEPARATED FROM THE ELECTRODE. THE MATERIAL WAS REMOVED FROM THE PATIENT AND NOTHING REMAINS. THERE WAS NO PATIENT INJURY. SITE STATED THAT THE PRODUCT WAS NOT REUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPOLAR TRIGGER-FLEX PROBE GEI ELLMAN INT'L INC. DTF-40 080101295

    Patients

    Seq Age Sex Outcome Treatment
    1