BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR FORCEPS

    MDR report key: 1349345 · Received December 18, 2006

    Report

    Report Number
    1530493-2006-00001
    Event Type
    Other
    Date Received
    December 18, 2006
    Date of Event
    June 20, 2005
    Report Date
    December 18, 2006
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DETERMINED TO HAVE BEEN MIS-USED. TESTING INDICATED END-USER ENGAGED INSTRUMENT MORE THAN REQUIRED AND/OR INCREASED VOLTAGE TO DEVICE. WE RETURNED DEVICE TO THE CUSTOMER WITH NO REPAIR FOR THEIR DISPOSITION.

    Description of Event or Problem · 1

    OLSEN MEDICAL RECEIVED A CALL FROM OUR CUSTOMER. THE CUSTOMER NOTED THAT A PATIENT RECEIVED A BURN DURING A BREAST AUGMENTATION. THE BURNT TISSUE WAS EXCISED. OLSEN CONDUCTED AN INVESTIGATION ON THE DEVICE. THE LEGS OF THE INSTRUMENT WAS MARRED WITH FISSURES, INDICATING PROLONGED TIP-CONTACT OR HIGH ENERGIZATION. PER THE INFORMATION RELAYED TO US, THE PATIENT DID NOT NEED FURTHER SURGERY, AND THE SURGERY LASTED NO LONGER THAN INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR FORCEPS MONOPOLAR FORCEPS GEI OLSEN MEDICAL 12001 116822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other