BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP

    MDR report key: 2945222 · Received January 31, 2013

    Report

    Report Number
    1045254-2013-00056
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    July 7, 2009
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HQP
    PMA / PMN Number
    K833648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND FUNCTIONAL EXAM OF THE RETURNED DEVICES FOUND THE DEVICES HAD BLOWN TIPS (FRACTURED WITHOUT FRAGMENTS). FURTHER INSPECTION SHOWED THE WIRE TIPS HAD SHRIVELED INDICATING SUPPLIED MATERIAL. THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE CUSTOMER HAVE BEEN UNPRODUCTIVE. HOWEVER, THE INSTRUCTIONS FOR USE INCLUDE FIRE WARNINGS, I.E. "HEAT GENERATED BY THE TIP CAN IGNITE FLAMMABLE MATERIALS. DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS SUCH AS FACIAL HAIR, PREPARATION AGENTS, ALCOHOL VAPORS, DRAPES, OR GOWNS". NOTE: THIS PRODUCT IS NO LONGER MFG BY MEDTRONIC, INC. THE PRODUCT LINE WAS SOLD TO ANOTHER MFR MID-2011.

    Description of Event or Problem · 1

    THIS REPORT IS PROVIDED AS PART OF A RETROSPECTIVE REVIEW, AND WAS PERFORMED AS THE RESULT OF CHANGES/IMPROVEMENTS TO PRODUCT SPECIFIC CRITERIA DEVELOPED TO MAKE MEDICAL DEVICE REPORT (MDR) DECISIONS, PER DISCUSSION WITH OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB). THIS CHANGE/IMPROVEMENT, WHICH WAS INITIATED IN (B)(4) 2012, HAS RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY THE MFR - THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF ANY NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE SUBMISSION CRITERIA. THE CUSTOMER STATED THAT THE TIP OF THE ONE ACCU-TEMP CAUTERY TOOL CAUGHT FIRE WHEN THE DOCTOR PRESSED THE BUTTON IN THE BEGINNING OF THE PROCEDURE AND ANOTHER ACCU-TEMP CAUTERY STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY OR DELAY OF PROCEDURE. NO F/U TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43179 CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP HQP - UNIT, CAUTERY, THERMAL, BATTERY-POWERED HQP MEDTRONIC XOMED, INC. 8442000 60777000

    Patients

    Seq Age Sex Outcome Treatment
    1