BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF RESECTION 90 DEGREE ELECTRODE NEEDLE 24-28FR 12 DEGREES

    MDR report key: 4093165 · Received August 21, 2014

    Report

    Report Number
    2951238-2014-00318
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2014
    Manufacturer
    OLYMPUS WINTER AND IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED TO IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC DIRECT VISION INTERNAL URETHROTOMY (DVIU) OF A BLADDER CONTRACTURE, WHILE PERFORMING THE INCISION ON THE BLADDER NECK, TWO SEPARATE DEVICES BURNT OUT AT THE BEGINNING OF THE PROCEDURE. BOTH DEVICES WERE REPLACED AND THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD SIMILAR DEVICE. AN INSPECTION OF THE DAMAGED DEVICES SHOWED A FRACTURED COLINS KNIFE TIP. IT WAS STATED THAT THE PROCEDURE WAS PROLONGED BY THIRTY MINUTES. THE PHYSICIAN STATED THAT THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS EXCELLENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506786 HF RESECTION 90 DEGREE ELECTRODE NEEDLE 24-28FR 12 DEGREES RESECTION ELECTRODE FAS OLYMPUS WINTER AND IBE GMBH A22253C 13277P02L001

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other MFR REPORT # 2951238-2014-00317| MODEL # A22253C, SERIAL # (B)(4),