BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 9314581 · Received November 13, 2019

    Report

    Report Number
    9610773-2019-00160
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 18, 2019
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE INVESTIGATION/EVALUATION WAS PERFORMED EXCLUSIVELY ON THE BASIS OF THE INFORMATION PROVIDED BY THE CUSTOMER. THERE WERE NO REPORTS OF ANY MALFUNCTION OF THE GENERATOR. 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, THE INSTRUCTIONS FOR USE CONTAIN SEVERAL WARNING NOTES REFERRING TO POSSIBLE RISKS AND COMPLICATIONS WHEN USING THE HF GENERATOR. FOR EXAMPLE, MECHANICAL STRESS AT THE TREATMENT SITE WHEN USING A SNARE CAN RESULT IN BLEEDING AND PERFORATION TO THE PATIENT. THIS MAY HAPPEN, FOR EXAMPLE, IF THE SNARE IS CLOSED FOR CUTTING BEFORE THE HF CURRENT IS ACTIVATED. ALSO, INAPPROPRIATE OUTPUT OF POWER CAN RESULT IN BLEEDING, PERFORATION AND BURNS TO THE PATIENT. BASED ON THE INFORMATION AVAILABLE, IT MUST BE ASSUMED THAT THE REPORTED EVENT/INCIDENT WAS MOST LIKELY CAUSED BY USE ERROR. 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. 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. 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 COLONOSCOPY WITH POLYPECTOMY PROCEDURE, THE PATIENT MAY HAVE SUSTAINED A BOWEL PERFORATION IN THE AREA OF THE HEPATIC ANGLE. SEVERAL HOURS AFTER THE COLONOSCOPY WITH POLYPECTOMY PROCEDURE OF TWO SESSILE POLYPS HAD BEEN PERFORMED, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL DUE TO ABDOMINAL PAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110236 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003W

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization UNSPECIFIED 10 MM POLYPECTOMY LOOP| UNSPECIFIED 10 MM POLYPECTOMY LOOP