BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL UNIT PSD-20

    MDR report key: 3810372 · Received April 11, 2014

    Report

    Report Number
    8010047-2014-00162
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE PHENOMENON WAS NOT REPRODUCED, AND THERE WAS NO BURNED PORTION. THERE WAS NO PROBLEM FOUND WITH THE PSD-20. THE PARTIAL DISCONNECTION INSIDE OF THE A CORD OR INCOMPLETE CONNECTION OF THE A CORD AND THE SOCKET OF THE PSD-20 MAY HAVE CAUSED THE RISING OF THE ELECTRICAL RESISTANCE AND EVENTUALLY IT MAY HAVE HEATED UP AND SMOKED. THE PSD-20 INSTRUCTION MANUAL ALREADY STATES; -CONFIRM THAT THE A CORD (B)(4) CABLE AND PLUGS ARE FREE OF SCRATCHES AND CRACKS. INSERT THE PSD-20 SIDE OF THE A CORD PLUG INTO THE ACTIVE CONNECTOR ON THE PSD-20 FRONT PANEL UNTIL A CLICK SOUND IS HEARD. -TO ENSURE THAT THE PROCEDURE CAN BE COMPLETED WITHOUT COMPLICATION IN THE EVENT THAT THE PSD-20 MALFUNCTIONS, PREPARE A SPARE PSD-20 FOR BACKUP. SHOULD ANY ABNORMAL OUTPUT BE SUSPECTED DURING OPERATION, IMMEDIATELY TERMINATE THE USE OF THE EQUIPMENT AND TURN OFF THE POWER SWITCH. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SOCKET OF A CORD SMOKED WHEN THE FOOT SWITCH WAS CONTINUOUSLY OPERATED BECAUSE OF THE DEVICE WAS NOT ACTIVATED FOR OUTPUT. THE EST WAS CANCELED, AND THE PROCEDURE WAS CHANGED TO AND WAS COMPLETED WITH THE ENBD TUBE LEFT IN THE PT. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221615 ELECTROSURGICAL UNIT PSD-20 ELECTROSURGICAL UNIT KNS OLYMPUS MEDICAL SYSTEMS CORPORATION PSD-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other