BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 6311748 · Received February 8, 2017

    Report

    Report Number
    9610773-2017-00004
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 11, 2017
    Report Date
    April 5, 2018
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    PMA / PMN Number
    PK141225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE. DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), JAPAN (RETURNED TO OMSC ON 2017-02-01). WHEN THE ESG-400 ELECTROSURGICAL GENERATOR WAS INSPECTED AND TESTED, IT WAS FOUND TO BE IN GOOD WORKING ORDER AND IN ACCORDANCE WITH ITS SPECIFICATIONS. NO ABNORMALITY, DEFECT, FAILURE OR MALFUNCTION WAS FOUND DURING THE PERFORMANCE TESTS. FURTHERMORE, A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE ESG-400 ELECTROSURGICAL GENERATOR WITHOUT SHOWING ANY ABNORMALITIES RELATED TO THE REPORTED PHENOMENON. THEREFORE, THE EXACT CAUSE OF THE COMPLICATION AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IT CAN BE EXCLUDED THAT IT WAS CAUSED BY A MALFUNCTION OF THE ESG-400 ELECTROSURGICAL GENERATOR. IN GENERAL, THE OCCURRENCE OF BLEEDING DURING OR AFTER A PROCEDURE IS AN EXPECTED AND FORESEEABLE SIDE EFFECT, CLEARLY IDENTIFIED IN LABELING AND RISK ASSESSMENT WITH JUSTIFICATION OF BENEFIT. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE REPORTED PHENOMENON WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4) (RETURNED TO OMSC ON 2017-02-01). HOWEVER, THE EXACT CAUSE OF THE COMPLICATION AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED YET SINCE THE EVALUATION/INVESTIGATION IS STILL ONGOING. AS SOON AS THE INVESTIGATION RESULTS AND FINAL EVALUATION ARE AVAILABLE, THIS REPORT WILL BE UPDATED. PLEASE NOTE: THIS REPORT IS BEING SUBMITTED ALTHOUGH THE SUSPECT MEDICAL DEVICE IS NOT MARKETED IN THE USA. HOWEVER, A SIMILAR DEVICE IS MARKETED. MODEL # / CATALOG #: WB91051W; BRAND NAME: HF UNIT "ESG-400"; COMMON DEVICE NAME: HF- GENERATORS; 510(K): K141225; PRODUCT CODE: GEI.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE, UNINTENDED NERVE AND MUSCLE STIMULATION OCCURRED MORE FREQUENTLY THAN EXPECTED AND THE RESECTION SHEATH BECAME HOT. POSTOPERATIVELY, THE PATIENT DEVELOPED A URETHRAL STRICTURE. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT OF MALFUNCTION FOR ANY OF THE MEDICAL DEVICES INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92866 HF UNIT "ESG-400" HF- GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNSPECIFIED RESECTION SHEATH| UNSPECIFIED RESECTION SHEATH