BEUDAMED
    FDA Adverse Event Death Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 8844795 · Received July 31, 2019

    Report

    Report Number
    9610773-2019-00096
    Event Type
    Death
    Date Received
    July 31, 2019
    Date of Event
    July 4, 2019
    Report Date
    August 16, 2019
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: DEVICE MANUFACTURE DATE; DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS SHANGHAI (OSH), (RETURNED TO OSH ON 2019-08-12). THE EVALUATION/INVESTIGATION DID NOT REVEAL ANY ABNORMALITY, DEFECT, FAILURE OR MALFUNCTION REGARDING THE HF GENERATOR. HOWEVER, THE ATTACHED HF CABLE SHOWED CONSIDERABLE SIGNS OF WEAR AND TEAR AND EVEN PINHOLE DAMAGE. THUS, THE REPORTED MALFUNCTION WAS MOST LIKELY CAUSED BY THE DEFECTIVE HF CABLE AND THEREFORE CAN BE ATTRIBUTED TO USE ERROR DUE TO POOR/INADEQUATE MAINTENANCE. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND RETRAINED TO CORRECTLY USE THE OLYMPUS MEDICAL DEVICES.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/ INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENT'S OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES 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 ONE DAY AFTER A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE PATIENT WAS TRANSFERRED TO ICU AND PASSED AWAY DUE TO MASSIVE HEMORRHAGE. THE USER FACILITY REPORTED THAT THE HEMOSTASIS WAS POOR INTRAOPERATIVELY. HOWEVER, THE TURP WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. AN ON-SITE INVESTIGATION ON (B)(6) 2019 REVEALED THAT THE HF CABLES OF THE GENERATOR AND SPARE GENERATOR (UES-40) DID NOT FUNCTION CORRECTLY RELATED TO CONTACT QUALITY AND ELECTRICITY LEAKAGE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642084 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 Death OLYMPUS SURGMASTER ELECTROSURGICAL UNIT (UES-40)| OLYMPUS UNSPECIFIED HF CABLES| OLYMPUS SURGMASTER ELECTROSURGICAL UNIT (UES-40)| OLYMPUS UNSPECIFIED HF CABLES