BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 1827442 · Received September 2, 2010

    Report

    Report Number
    8010047-2010-00170
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT HAS BEEN RECEIVED AND IS BEING EVALUATED. THE EXACT CAUSE OF THE PATIENT'S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICAN INC IS FILING MDRS ON BEHALF OF (B)(6) AND OLYMPUS MEDICAL SYSTEMS CORP. (B)(4). CROSS-REFERENCED MFR REPORT NUMBER 9610773-2010-00028 FOR THE ASSOCIATED DEVICE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT EARLY IN A THERAPEUTIC RESECTION OF PROSTATE (TURP) PROCEDURE THE PHYSICIAN HAD REQUESTED THE IRRIGATION METHOD BE CHANGED. THE PROCEDURE WAS STOPPED, AND WHEN RE-STARTED, THE PHYSICIAN REPORTEDLY ENCOUNTERED A LARGE AMOUNT OF BUBBLES IN THE FIELD OF VIEW THAT MADE VISUALIZATION DIFFICULT. THE PROCEDURE WAS AGAIN STOPPED, AND THE USERS DETERMINED THAT THE NON-OLYMPUS PUMP TUBING HAD BEEN INSTALLED BACKWARDS. THE TUBING WAS CORRECTED AND THE PROCEDURE RESUMED. AFTER APPROXIMATELY FIVE MINUTES OF RESECTION, THE PATIENT REPORTEDLY MOVED AND A LOUD POP WAS HEARD. THE PROCEDURE WAS STOPPED AGAIN, AND IT WAS DETERMINED A PERFORATION OF THE BLADDER HAD OCCURRED. THE PATIENT WAS TRANSFERRED TO A DIFFERENT OPERATING ROOM FOR SURGICAL INTERVENTION, AND THE TREATING PHYSICIAN REPORTEDLY DISCOVERED TWO PERFORATIONS IN THE BLADDER. THE USER ATTRIBUTED THE CAUSE OF THE EVENT TO A BUBBLE IGNITION, HOWEVER, MECHANICAL PERFORATION ASSOCIATED WITH PATIENT MOVEMENT AND/OR REDUCED VISIBILITY CANNOT BE EXCLUDED AS CONTRIBUTORY FACTORS. THE PT IS REPORTEDLY DOING FINE FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT KNS OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4), AND IRRIGATION PUMP MODEL UNKNOWN.| OLYMPUS RESECTION ELECTRODE MODEL WA22302D WITH | OLYMPUS RESECTION ELECTRODE MODEL WA22302D WITH| (B)(4), AND IRRIGATION PUMP MODEL UNKNOWN.