BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 7081969 · Received December 5, 2017

    Report

    Report Number
    9610773-2017-00131
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 28, 2017
    Report Date
    February 28, 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 EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT 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, A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE ESG-400 ELECTROSURGICAL GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS NOT 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 DURING A THERAPEUTIC CERVICAL POLYPECTOMY PROCEDURE, THE PATIENT WAS TWITCHING AND HER BLOOD PRESSURE AND HEART RATE COLLAPSED. AFTER REVITALIZATION MEASURES HAVE BEEN TAKEN, THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT. THE PATIENT REPORTEDLY RECOVERED AND THERE WAS NO REPORT OF ANY EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861299 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R HF CABLE, BIPOLAR, 4 M, FOR ESG-400 (WA00014A)| VISERA ELITE VIDEO PROCESSOR OTV-S190| WORKING ELEMENT, PASSIVE (WA22367A)| HF CABLE, BIPOLAR, 4 M, FOR ESG-400 (WA00014A)| VISERA ELITE VIDEO PROCESSOR OTV-S190| WORKING ELEMENT, PASSIVE (WA22367A)