BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT ONLY F/MODULAR MONOPOL.ELECTR

    MDR report key: 22740152 · Received August 7, 2025

    Report

    Report Number
    9610612-2025-00171
    Event Type
    Malfunction
    Date Received
    August 7, 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

    ADDITIONAL INFORMATION : H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, PICTURES AND EVENT DESCRIPTION. MANY IMAGES WERE PROVIDED. THE BODIES OF THE HOOK ELECTRODES APPEAR TO BE IN A COMPLETE AND PROPER CONDITION. THE CHARRED AREAS AT THE FRONT END OF THE OUTER TUBE(S) WAS SHOWN. IT IS IMPORTANT TO VISUALLY INSPECT THE SURFACE OF THE OUTER TUBE AND ITS EDGE AT THE TRANSITION POINT TO THE ELECTRODE BEFORE USE. NO CRACKS, BURNS, OR OTHER SURFACE CHANGES SHOULD BE VISIBLE. BATCH HISTORY REVIEW: A BATCH HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER COULD NOT BE IDENTIFIED. EVEN AFTER FAITHFUL ATTEMPTS FOR RETRIEVAL, NO FURTHER INFORMATION COULD BE RECEIVED. 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. CONCLUSION/ PREVENTIVE MEASURES: THE COMPLAINED PROBLEM COULD BE CONFIRMED. WITHOUT FURTHER KNOWLEDGE OF THE CIRCUMSTANCES, IT IS ASSUMED THAT THERE WAS MOISTURE (BLOOD, TISSUE FLUID, SALINE SOLUTION) PRESENT IN THE CAPILLARY BETWEEN THE SHAFT AND THE OUTER TUBE AND BETWEEN THE OUTER TUBE AND THE INSULATION OF THE ELECTRODE. DUE TO THE HIGH RF- TENSION, A CURRENT LEAKING PATH CAN ARISE FROM BETWEEN THE ELECTRICALLY CONDUCTIVE SHAFT AND THE TISSUE AND THE METAL TROCAR THROUGH THE GAP BETWEEN THE OUTER TUBE AND THE INSULATION OF THE ELECTRODE. THE HEAT GENERATED BY THIS LEAKAGE CURRENT MELTS AND CHARRED THE OUTER TUBE. SINCE THE INSULATION MATERIAL OF THE ELECTRODE HAS A MUCH HIGHER MELTING POINT, THIS EFFECT DOES NOT OCCUR HERE, OTHERWISE THE SAME DAMAGE WOULD ALSO OCCUR ON THE ELECTRODE ("GREY") SIDE. THE CAUSE OF THE LEAKAGE CURRENT IS THEREFORE THE INCOMPLETE TIGHTNESS OF THE CONNECTION BETWEEN THE TWO INSULATION POINTS (OUTER TUBE AND INSULATOR OF THE ELECTRODE) AND THE MOISTURE BETWEEN THE SHAFT AND THE OUTER TUBE. THE DAMAGE TO THE EDGES AND FRONT PARTS OF THE OUTER TUBES CAUSED BY LEAKAGE CURRENTS AND ARCING IS SO SEVERE THAT IT CANNOT HAVE OCCURRED WITHIN A SINGLE APPLICATION; THERE MUST HAVE BEEN PRESENT PRIOR DAMAGE(S). THE PRODUCT LIFE CYCLE OF THIS ARTICLE GUARANTEES 20 APPLICATIONS / REPROCESSINGS AND THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS CHECKING THE INSTRUMENTS FOR DAMAGE AND SURFACE CHANGES BEFORE USE. THESE PARTS WITH THE CORRESPONDING SURFACE ABNORMALITIES SHOULD NO LONGER HAVE BEEN USED. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK370P - SHAFT ONLY F/MODULAR MONOPOL.ELECTR. 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. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). ASSOCIATED MEDWATCH REPORTS: GK370P ( (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00170), GK370P ( (AESCULAP AG REFERENCE NO. (B)(4). 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).

    Description of Event or Problem · 0

    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
    501288 SHAFT ONLY F/MODULAR MONOPOL.ELECTR HANDHELD PRODUCTS & LIGATION GEI AESCULAP AG GK370P

    Patients

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