BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 9627129 · Received January 24, 2020

    Report

    Report Number
    9610773-2020-00052
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    January 21, 2020
    Report Date
    March 27, 2020
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THE EVALUATION/INVESTIGATION DID NOT REVEAL ANY MALFUNCTIONS OF THE HF-GENERATOR 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 HF GENERATOR 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, IT IS CLEARLY STATED IN THE INSTRUCTIONS FOR USE THAT MECHANICAL STRESS AT THE TREATMENT SITE WHEN USING A SNARE CAN RESULT IN BLEEDING AND PERFORATION TO THE PATIENT. SINCE THERE WERE ALSO NO REPORTS OF ANY MALFUNCTIONS OF THE HF-GENERATOR, THE EVENT/INCIDENT WAS THUS ATTRIBUTED TO USE ERROR. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, 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. 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 #: WA90300W; BRAND NAME: ELECTROSURGICAL GENERATOR "ESG-300"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K180200; PRODUCT CODE: GEI.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC CECAL POLYPECTOMY PROCEDURE THE PATIENT SUSTAINED A PERFORATION OF THE CECUM. THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS. THE INTENDED PROCEDURE WAS COMPLETED WITH AN INTERVENTION PROCEDURE. THE PERFORATION WAS TREATED USING ENDOCLIPS AND THE PATIENT RECEIVED ANTIBIOTIC TREATMENT AND WAS HOSPITALIZED FOR ONE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91595 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003W

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNSPECIFIED MONOFILAMENT SNARE FOR POLYPECTOMY