BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA 3F URETEROSCOPIC BIOPSY DEVICE

    MDR report key: 2150448 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02132
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PIRANHA URETEROSCOPIC BIOPSY FORCEP KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. A VISUAL INSPECTION OF THE DEVICE INDICATED THAT 2 CM OF THE COIL AND CORE WIRE IS MISSING AND WAS EITHER CUT OR SHEARED OFF. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PIRANHA URETEROSCOPIC BIOPSY FORCEP LOT # 9425533 CONTAINED IN THE PIRANHA URETEROSCOPIC BIOPSY FORCEP KIT WAS PERFORMED; NO ANOMALIES WERE NOTED. THE (B)(6) 2008, 15-MONTH UROLOGY PIRANHA PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO FAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON (B)(6) 2008 THAT A PIRANHA URETEROSCOPIC BIOPSY FORCEP DEVICE WAS USED FOR A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE FORCEPS FAILED TO OPEN IN THE PT. THE PHYSICIAN REMOVED THE FORCEPS AND TRIED THE PROCEDURE AGAIN (USING THE SAME FORCEPS) AND ONE OF THE JAWS BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIRANHA 3F URETEROSCOPIC BIOPSY DEVICE FCL BOSTON SCIENTIFIC CORPORATION M0065051600 9425533

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK