BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN #65000 REUSABLE DIATHERMY PEN

    MDR report key: 2257329 · Received July 29, 2011

    Report

    Report Number
    1530493-2011-00003
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    OLSEN MEDICAL
    Product Code
    HQO
    PMA / PMN Number
    PRE-AMEND
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. PICTURES WERE SENT AND FROM VISUAL EVAL, THE DAMAGE WAS CONSISTENT WITH OTHER PAST HISTORICAL ISSUES OF SIMILAR PRODUCT CORD PLUG INTERFACE. THESE ISSUES HAVE BEEN TRACED TO IMPROPERLY REMOVING PLUG FROM THE GENERATOR BY PULLING ON CORD NOT PLUG AND/OR USING THE INSTRUMENT TOO MANY TIMES AND NOT INSPECTING FOR DAMAGE PRIOR TO USE. PROPER MAINTENANCE, CARE, AND INSPECTION OF THE DEVICE IS IMPORTANT FOR SAFE OPERATION.

    Description of Event or Problem · 1

    HOSPITAL AUTHORITY CONTACTED DISTRIBUTOR (B)(6), 2011 TO INQUIRE HOW TO CHECK INSTRUMENT FOR SAFETY. FURTHER INVESTIGATION DETERMINED THAT THEY HAD A MODEL #65000 DIATHERMY PEN THAT HAD A BURNED CORD AT THE ATTACHMENT OF THE CORD TO THE PLUG. THEY REPORTED THAT NO PT OR STAFF WERE HURT OR INVOLVED IN THE INCIDENT, AND THAT NO LOT NUMBER COULD BE IDENTIFIED. THEY SUPPLIED PHOTOS, BUT DID NOT RETURN INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN #65000 REUSABLE DIATHERMY PEN REUSABLE DIATHERMY PEN HQO OLSEN MEDICAL 65000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1