BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 2600476 · Received May 31, 2012

    Report

    Report Number
    8010047-2012-00169
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 2, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2012-00169. OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED. THE REFERENCED DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC EVALUATED THE DEVICE AND FOUND THAT THERE WAS NO ABNORMALITY AND IRREGULARITY. THEREFORE, THE CONCLUSION OF THIS ISSUE IS NO DIFFERENT FROM THE INITIAL REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS NOT RETURNED TO THE OLYMPUS MEDICAL SYSTEMS CORPORATION FOR EVALUATION. THE OLYMPUS (B)(4) EVALUATED THE REFERENCED DEVICE AND FOUND THAT THE UES-40 HAD NO ABNORMALITY. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS THE POSSIBILITY OF THE USER MISHANDLING. OLYMPUS CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THE REFERENCE DEVICE WILL BE RETURNED TO THE OLYMPUS MEDICAL SYSTEMS CORPORATION FOR INSPECTION. THERE WERE NO FURTHER DETAILS PROVIDED. HOWEVER, OLYMPUS CONTINUES TO FOLLOW UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFO. IF SIGNIFICANT ADDITIONAL INFO IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIC UROLOGICAL ENDOSCOPIC PROCEDURE THE RESECTOSCOPE GOT HOT AND IT WAS DIFFICULT TO CARRY ON THE PROCEDURE. SOME DAYS AFTER, THE PT CAME BACK TO THE HOSPITAL BECAUSE OF INCONTINENCE. THERE WERE BLISTERS ON THE TISSUE OF THE PT AND SOME BLISTERS BECAME SCARS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention