BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIWAND II 5MM SUC/IRR W/CAUT/L-HOOK

    MDR report key: 3222107 · Received July 1, 2013

    Report

    Report Number
    2647580-2013-00368
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    HET
    PMA / PMN Number
    K903207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GYNECOLOGY. ACCORDING TO THE REPORTER: SURGIWAND II DIATHERMY TIP MELTED THE PLASTIC SHEATH. END OF PLASTIC SHEATH FELL OFF INTO THE PATIENT, THAT PIECE WAS REMOVED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297428 SURGIWAND II 5MM SUC/IRR W/CAUT/L-HOOK DISPOSABLE SURGICAL ACCESSORY HET COVIDIEN, FORMERLY USSC P3A0749X

    Patients

    Seq Age Sex Outcome Treatment
    1