BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 4161606 · Received July 23, 2014

    Report

    Report Number
    8010047-2014-00397
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, THEREFORE OMSC COULD NOT EVALUATE THE REFERENCED DEVICE. BASED ON THE SIMILAR CASES WITH THE SIMILAR MODEL, IT IS KNOWN THAT THE EXPOSED CUTTING WIRE FROM THE DAMAGED COATING CONTACTED OR CAME CLOSE TO THE METAL PART OF THE FORCEPS ELEVATOR WHILE ACTIVATING THE OUTPUT, WHICH CAUSED A SPARK AND A PART OF THE CUTTING WIRE BECAME EXTREMELY HOT, RESULTING IN BREAKAGE. ALSO, THE DAMAGE OF THE COATING OCCURRED DUE TO CONTACTING WITH THE METAL PART OF THE FORCEPS ELEVATOR OF THE ENDOSCOPE. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED UPON THE FINDINGS OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFO IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE 8010047-2013-00394/00395/00396.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) WITH SPHINCTEROTOME IN COMBINATION WITH THE PSD-60, THE CUTTING WIRE BROKE AS SOON AS THE PHYSICIAN ACTIVATED THE HF OUTPUT. HE USED OTHER KDS BUT THE CUTTING WIRES OF TWO DEVICES BROKE IN A ROW. HE SAW A FLASH LIKE DISCHARGE ON THE ENDOSCOPIC IMAGE WHEN THE CUTTING WIRE BROKE. HE EXCHANGED PSD-60 TO NON-OLYMPUS ELECTRO SURGICAL UNIT AND COMPLETED THE PROCEDURE WITH NEW (B)(4). THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430750 OLYMPUS ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT KNS OLYMPUS MEDICAL SYSTEMS CORPORATION PSD-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), LOT# K3921, MDR 8010047-2014-00395| (B)(4), LOT# K3924, MDR 8010047-2014-00396| (B)(4), LOT# K3923, MDR 8010047-2014-00394