BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 13789686 · Received March 16, 2022

    Report

    Report Number
    9610773-2022-00100
    Event Type
    Injury
    Date Received
    March 16, 2022
    Date of Event
    February 28, 2022
    Report Date
    May 3, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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): K203682; PRODUCT CODE: GEI.

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER; H4 - DEVICE MANUFACTURER DATE DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION NOR TO ANY REPAIR CENTER. THEREFORE, THE EVALUATION WAS PERFORMED EXCLUSIVELY ON THE BASIS OF THE AVAILABLE INFORMATION. BASED ON THE INFORMATION AVAILABLE, THE EXACT CAUSE OF THE REPORTED PHENOMENON AND THE PATIENT¿S OUTCOME COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. SINCE THERE WAS NO REPORT OF ANY MALFUNCTION, THE HF GENERATOR MOST LIKELY WAS IN STANDARD CONDITION AT THE TIME OF THE INCIDENT. A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE HF GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT AFTER A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOUR (TUR-BT) PROCEDURE THE PATIENT COMPLAINED OF ABDOMINAL PAIN. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND A SMALL BOWEL PERFORATION WAS IDENTIFIED, WHICH, HOWEVER, DID NOT REQUIRE ANY ADDITIONAL MEDICAL TREATMENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT A MALFUNCTION OF ANY OF THE OLYMPUS DEVICES USED DURING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767458 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other OLYMPUS HF-CABLE, BIPOLAR (WA00014A)| OLYMPUS HF-RESECTION ELECTRODE (WA22301D)| OLYMPUS TELESCOPE, 12°, 4 MM (A22001A)| OLYMPUS WORKING ELEMENT, PASSIVE (WA22367A)