BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWITCH-BLADE SCISSOR REUSE HDLE 5MM 45CM

    MDR report key: 3080542 · Received April 26, 2013

    Report

    Report Number
    1038548-2013-00011
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CAREFUSION
    Product Code
    GEI
    PMA / PMN Number
    K030890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IN THE CASE OF THIS COMPLAINT NO DEVICE WAS AVAILABLE FOR EVALUATION. CAREFUSION BECAME AWARE OF THIS COMPLAINT WHEN COMPLAINT (B)(4) WAS FILED BY THE FACILITY. A DEVICE EVALUATION WAS DONE ON THE PRODUCT WHICH IS THE SAME, ON COMPLAINT (B)(4). A MEDWATCH HAS ALSO BEEN FILED IN THE OTHER EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPOSABLE TIP FELL OFF INTO THE PATIENT. IT WAS RETRIEVED WITH NO PATIENT HARM. CLINICAL USE AT THE TIME WAS NOT CLEAR. NO SAMPLE IS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181260 SWITCH-BLADE SCISSOR REUSE HDLE 5MM 45CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION SP90-1250 DEVICED NOT RECEIVED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other