BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION ELECTRODE

    MDR report key: 1842668 · Received September 2, 2010

    Report

    Report Number
    9610773-2010-00028
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS DISCARDED BY THE USER FACILITY. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFO BECOMES AVAILABLE LATER A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. (B)(4). CROSS-REFERENCE MFR REPORT NUMBER 8010047-2010-00170 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 APPROX FIVE MINS OF RESECTION, THE PT 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 PT WAS TRANSFERRED TO A DIFFERENT OPERATING ROOM FOR SURGICAL INTERVENTION, AND THE TREATING PHYSICIAN REPORTEDLY DISCOVERED TWO PERFORATIONS IN THE BLADDER. THE PT IS REPORTEDLY DOING FINE FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTION ELECTRODE ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22302D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL UNK| IRRIGATION PUMP: MODEL UNK| OLYMPUS ELECTROSURIGICAL UNIT: MODEL UES-40 | SN # (B)(6)| OLYMPUS ELECTROSURIGICAL UNIT: MODEL UES-40| SN # (B)(4)| IRRIGATION PUMP: MODEL UNK| CATHETER: MODEL UNK