BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 16612626 · Received March 24, 2023

    Report

    Report Number
    9610773-2023-00867
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    February 23, 2023
    Report Date
    June 25, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH: BERLIN
    Product Code
    GEI
    PMA / PMN Number
    K203682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS. DURING THEIR INSPECTION, THE SBC CONFIRMED THE REPORTED ISSUE. THE SBC REPRODUCED THE ERROR AND TRACED IT BACK TO THE LVPS CONNECTION CABLE. FURTHERMORE, THE SBC IDENTIFIED THE FOLLOWING ADDITIONAL ISSUES: THE SBC REPORTED THE OCCURRENCE OF ERROR MESSAGE E460 AND TRACED THE ERROR BACK TO A DEFECTIVE GENERATOR BOARD. THE SBC REPORTED CRACKS AND CHIPPING ON THE FRONT PANEL. THE SBC DID NOT PROVIDE DETAILED PHOTOS OF THE REPORTED ISSUE. ACCORDING TO THE SBC, THE CONNECTION CABLE BETWEEN THE MOTHERBOARD AND THE DISPLAY WAS REPAIRED BY A THIRD PARTY. NO DETAILS WERE PROVIDED ABOUT THE KIND OF DAMAGE. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A GENERATOR (HF UNIT) HAD AN E172 ERROR. THERE WAS NO PROCEDURE INVOLVED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377457 HF UNIT "ESG-400" ELECTROSURGICAL GEI OLYMPUS WINTER & IBE GMBH: BERLIN WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown