BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGON PLASMA COAGULATION UNIT "APU-300"

    MDR report key: 11789035 · Received May 7, 2021

    Report

    Report Number
    9610773-2021-00131
    Event Type
    Death
    Date Received
    May 7, 2021
    Report Date
    June 9, 2021
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    UDI-DI
    04042761083560
    PMA / PMN Number
    K180200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT THE OLYMPUS REGIONAL REPAIR CENTER (RRC) HAMBURG, GERMANY (RECEIVED AT THE RRC ON 2021-05-06). THE EVALUATION AT THE RRC DID NOT REVEAL ANY MALFUNCTIONS OF THE ARGON PLASMA COAGULATION UNIT OR THE CONCOMITANT ESG-300 HF GENERATOR BUT FOUND BOTH DEVICES TO BE WORKING CORRECTLY. FURTHERMORE, THERE WERE NO REPORTS OF ANY MALFUNCTION OF ANY OF THE OLYMPUS MEDICAL DEVICES USED DURING THE INITIAL PROCEDURE. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION FOR A TECHNICAL DEFECT THAT MIGHT HAVE CONTRIBUTED TO THE PATIENT¿S DEATH. THE EXACT CAUSE OF THE REPORTED PHENOMENON AND THE PATIENT¿S OUTCOME COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBERS OF BOTH THE ARGON PLASMA COAGULATION UNIT AND THE CONCOMITANT 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.

    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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER A THERAPEUTIC COLONOSCOPY PROCEDURE AT AN UNKNOWN DATE, WHERE THE COLON AND THE TRANSVERSUM WERE TREATED USING SMART ARGON, THE PROCEDURE WAS FIRST BELIEVED TO HAVE BEEN FINISHED NORMALLY, WHEN THE PATIENT'S CONDITION DETERIORATED AND A FOLLOW-UP PROCEDURE WAS PLANNED. HOWEVER, THE PATIENT PASSED AWAY BEFORE IT COULD BE CARRIED OUT. THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS DURING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685271 ARGON PLASMA COAGULATION UNIT "APU-300" ELECTROSURGICAL UNITS, MONOPOLAR, ARGON-ENHANCED COAGULATION GEI OLYMPUS WINTER & IBE GMBH WA90004W 04042761083560

    Patients

    Seq Age Sex Outcome Treatment
    1 Death OLYMPUS ELECTROSURGICAL GENERATOR "ESG-300"| OLYMPUS ELECTROSURGICAL GENERATOR "ESG-300".