BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR GOLD PROBE CABLE ADAPTER

    MDR report key: 1409292 · Received June 30, 2009

    Report

    Report Number
    1530493-2009-00005
    Event Type
    Other
    Date Received
    June 30, 2009
    Date of Event
    April 29, 2009
    Report Date
    June 29, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    PRE-AMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DEVICES WERE INVOLVED IN THIS INCIDENT. LOT NUMBER 000778 WAS MANUFACTURED IN (B)(4) 2006. LOT NUMBER 002589 WAS MANUFACTURED IN (B)(4) 2006. BASED UPON COLLABORATION WITH THE CUSTOMER, THE DEVICE WAS USED BEYOND TWENTY TIMES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OLSEN MEDICAL ON (B)(6) 2009 THAT A PT, AGE AND SEX UNK, WAS TREATED USING THE GOLD PROBE. THE GOLD PROBE CABLE ADAPTER IS MANUFACTURED BY OLSEN MEDICAL AND MATES WITH THE GOLD PROBE, A DEVICE NOT MANUFACTURED BY OLSEN MEDICAL. ACCORDING TO THE RECEIVED COMPLAINT, A PHYSICIAN REQUESTED A GOLD PROBE TO COMPLETE AN ANGIOPLASTY CASE AND THE GOLD PROBE DID NOT WORK. ANOTHER ONE WAS HANDED TO THE DOCTOR AND IT DID NOT WORK EITHER. PHYSICIAN DECIDED TO COMPLETE THE NEXT DAY AS PROCEDURE WAS NOT URGENT AND THE PT WAS REPORTED AS FINE. IT WAS LATER DISCOVERED A COMPONENT OF THE CABLE ADAPTER REMAINED ON THE GOLD PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR GOLD PROBE CABLE ADAPTER CABLE ADAPTER GEI OLSEN MEDICAL M00561360 000778

    Patients

    Seq Age Sex Outcome Treatment
    1 Other