BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 22508697 · Received July 15, 2025

    Report

    Report Number
    9610612-2025-00142
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 12, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 - UPDATED DESCRIPTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK384R - CERAMIC ELECTRODE TIP L-HK F/GK372R. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WERE SPARKS NEAR THE CONNECTION OF THE DEVICE COMPONENTS WHILE OPERATING ON THE PATIENT'S INTESTINES. SUBSEQUENTLY, AN INSULSCAN REVEALED THAT THERE WAS A SHORT CIRCUIT IN THE SAME AREA. NO ADDITIONAL INTERVENTION WAS NOTED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). ASSOCIATED MEDWATCH REPORTS: GK373R (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00141). GK384R (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00142).

    Description of Event or Problem · 0

    UPDATE: UPON REVIEW, IT WAS CONFIRMED THAT THE COMPLAINED PRODUCT IS INVOLVED AND NOT A LEADING MATERIAL. ASSOCIATED MEDWATCH REPORTS: GK370P ( (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00170). GK370P ( (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00171). INVOLVED COMPONENTS: GK373R (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00141). GK384R (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00142). GK373R (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00165). GK384R (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00166).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128221 CERAMIC ELECTRODE TIP L-HK F/GK372R HANDHELD PRODUCTS & LIGATION GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GK373R - LOT UNKNOWN| GK373R - LOT UNKNOWN| GK384R - LOT UNKNOWN| GK384R - LOT UNKNOWN