BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR FOOT ACTIVATED FORCEPS

    MDR report key: 1576382 · Received January 11, 2010

    Report

    Report Number
    1530493-2010-00001
    Event Type
    Other
    Date Received
    January 11, 2010
    Report Date
    January 8, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE HAD SCARRING AND SCRATCHES, EVIDENCE OF SOME TYPE OF RUBBING MOTION THAT CAUSED THE INSULATION FAILURE. THE REPORTER RETURNED THIS DEVICE STATING, "IT HAD INSULATION FAILURE AND BURNED A FEW PATIENTS." INFO WAS SOUGHT FOR THE PT PARTICULARS, AND NO OTHER INFO WAS PROVIDED. EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO OLSEN MEDICAL FROM A DISTRIBUTOR IN (B)(4) THAT A BURN TO A PT(S) WAS INVOLVED WITH A DEVICE FROM OLSEN MEDICAL. THERE ARE NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR FOOT ACTIVATED FORCEPS POTT-SMITH 9 3/4" FORCEPS GEI OLSEN MEDICAL 42402 012375

    Patients

    Seq Age Sex Outcome Treatment
    1 Other