BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGON PLASMA COAGULATION UNIT "APU-300"

    MDR report key: 9681367 · Received February 7, 2020

    Report

    Report Number
    9610773-2020-00066
    Event Type
    Death
    Date Received
    February 7, 2020
    Date of Event
    December 10, 2019
    Report Date
    April 21, 2020
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    UDI-DI
    04042761083560
    PMA / PMN Number
    K180200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE AND THE CONCOMITANT MEDICAL PRODUCTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THE EVALUATION/INVESTIGATION DID NOT REVEAL ANY MALFUNCTIONS OF THE ARGON PLASMA COAGULATION UNIT OR THE CONCOMITANT MEDICAL PRODUCTS BUT FOUND ALL ITEMS TO BE FUNCTIONING CORRECTLY. FURTHERMORE, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE ARGON PLASMA COAGULATION UNIT AND THE CONCOMITANT MEDICAL PRODUCTS WITHOUT SHOWING ANY ABNORMALITIES. 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. HOWEVER, IN GENERAL, THE OCCURRENCE OF BLEEDING/PERFORATION DURING OR AFTER ELECTROSURGICAL PROCEDURES IS AN EXPECTED AND FORESEEABLE SIDE EFFECT, CLEARLY IDENTIFIED IN LABELING AND RISK ASSESSMENT WITH JUSTIFICATION OF BENEFIT. 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 PROCEDURE TO STOP THE BLEEDING OF A VASCULAR LESION IN THE DUODENUM, THE PATIENT WAS FIRST RELEASED FROM HOSPITAL BUT THEN READMITTED 24-36 HOURS LATER DUE TO A PERITONITIS. THE PATIENT WAS ADMITTED TO ICU AND A LAPAROTOMY WAS PERFORMED WHICH FOUND A DUODENAL PERFORATION. THE PATIENT ALSO ENCOUNTERED FURTHER COMPLICATIONS ON ICU, ONE BEING AN INFECTION IN THE ARM. THE PATIENT DIED 4-6 DAYS AFTER BEING READMITTED. THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS DURING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147630 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 GENERATOR ESG-300 (WA90003W)| OLYMPUS PLASMA COAGULATION PROBE (WA94002A)| OLYMPUS GENERATOR ESG-300 (WA90003W)| OLYMPUS PLASMA COAGULATION PROBE (WA94002A)