BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 7246964 · Received February 7, 2018

    Report

    Report Number
    9610773-2018-00010
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    January 16, 2018
    Report Date
    May 3, 2018
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    PMA / PMN Number
    PK141225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 #: WB91051W; BRAND NAME: HF UNIT "ESG-400"; COMMON DEVICE NAME: HF- GENERATORS; 510(K): K141225; PRODUCT CODE: GEI.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4) (RETURNED TO OMSC ON 2018-02-08). THE INVESTIGATION FOUND THE ESG-400 ELECTROSURGICAL GENERATOR WITHIN ITS SPECIFICATION WITHOUT ANY ABNORMALITIES. THEREFORE, THE ROOT CAUSE OF THE REPORTED PHENOMENON IS MOST LIKELY A CONTACT BETWEEN THE PENCIL AND ANY METALLIC PART WHICH CAUSED THE SPARKING. THUS, THIS EVENT/INCIDENT WAS ATTRIBUTED TO USE ERROR. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND RETRAINED TO CORRECTLY USE THE OLYMPUS MEDICAL DEVICES.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC KNEE ARTHROSCOPY PROCEDURE, THE PATIENT SUSTAINED A THIRD-DEGREE BURN ON THE SKIN OF THE LEFT LEG AFTER THE TIP OF THE HF INSTRUMENT (UNSPECIFIED PENCIL) FROM A THIRD PARTY MANUFACTURER SPARKED. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT A MALFUNCTION OF THE ESG-400 ELECTROSURGICAL GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91676 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNSPECIFIED THIRD PARTY HF INSTRUMENT (PENCIL)