BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 10046379 · Received May 12, 2020

    Report

    Report Number
    9610773-2020-00117
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    April 30, 2020
    Report Date
    August 4, 2020
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT SUSTAINED A RUPTURE OF THE INTERNAL MUSCULARIS OF THE BLADDER. SINCE NO MALFUNCTION OF THE GENERATOR WAS REPORTED, IT CAN BE ASSUMED THAT THE DEVICE IS MOST LIKELY IN STANDARD. IT LIES IN THE RESPONSIBILITY OF THE USER TO MAKE SUITABLE SETTINGS FOR THE TISSUE SITUATION AT HAND AND TO ENSURE THE CORRECT DEPTH OF TREATMENT BY PROPERLY GUIDING THE INSTRUMENT. BASED ON THE INFORMATION PROVIDED, WE MUST ASSUME THAT THE REPORTED PATIENT INJURY WAS MOST LIKELY CAUSED BY IMPROPER HANDLING BY THE CUSTOMER. ACCORDING TO INFORMATION PROVIDED, PRODUCTS WA22367A, A22040A AND A22026A DID NOT SHOW ANY DAMAGE. AS A RESULT, THEY ARE ALSO ASSUMED TO BE IN STANDARD. HOWEVER, 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 AND THE CONCOMITANT DEVICES WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, 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 #: WB91051W; BRAND NAME: HF UNIT "ESG-400"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K141225; PRODUCT CODE: GEI.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC PLASMA PROSTATE ELECTROTOMY PROCEDURE, THE PATIENT SUSTAINED A RUPTURE OF THE INTERNAL MUSCULARIS OF THE BLADDER. THEREFORE, THE PROCEDURE WAS SWITCHED TO OPEN SURGERY TO TREAT THE RUPTURE WHICH LED TO A PROLONGATION OF SURGERY TIME NO LONGER THAN 15 MINUTES. ALSO, IT WAS REPORTED THAT THE SUBJECT DEVICE WAS INSPECTED PRIOR TO USE. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORTED MALFUNCTION OF ANY OF THE OLYMPUS MEDICAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512662 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR OLMPUS VIDEO PROCESSOR (CV-170)| OLYMPUS HF-RESECTION ELECTRODE LOOP (WA22302D)| OLYMPUS INNER SHEATH (A22040A)| OLYMPUS OUTER SHEATH (A22026A)| OLYMPUS WORKING ELEMENT (WA22367A)| OLMPUS VIDEO PROCESSOR (CV-170)| OLYMPUS HF-RESECTION ELECTRODE LOOP (WA22302D)| OLYMPUS INNER SHEATH (A22040A)| OLYMPUS OUTER SHEATH (A22026A)| OLYMPUS WORKING ELEMENT (WA22367A)