BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP J-HK F/GK372R

    MDR report key: 23353740 · Received October 21, 2025

    Report

    Report Number
    9610612-2025-00255
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 10, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTION: B5 - DESCRIPTION UPDATED. D1 - BRAND NAME. D4 - MODEL NUMBER UPDATED. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, REVIEW OF PICTURES, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE BATCH NUMBER WAS NOT PROVIDED. EVEN AFTER MEANINGFUL ATTEMPTS, NO FURTHER INFORMATION WAS 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 - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/ PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THE ISSUE COULD BE CONFIRMED VIA PHOTOGRAPH. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    UPDATE: THE MODEL NUMBER WAS UPDATED TO GK383R - CERAMIC ELECTRODE TIP J-HK F/GK372R.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK372R - HANDLE F/MONOPOLAR ELECTRODES 5MM VIA INFORMATION RECEIVED FROM MW5175620. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND LYSIS OF ADHESIONS IT WAS DISCOVERED THAT THE LIP OF THE J HOOK WAS MISSING. SUCTIONING WAS PERFORMED, AND THE PELVIS AND ABDOMEN WERE INSPECTED HOWEVER THE MISSING PIECE WAS NOT LOCATED. INTRAOPERATIVE ABDOMINAL AND PELVIC X-RAYS WERE PERFORMED, THE RESULTS CONFIRMING THE ABSENCE OF THE MISSING PIECE WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW HOOK WITHOUT COMPLICATION AND THE MISSING TIP WAS FOUND UNDER THE DRAPE NEXT TO THE PATIENT. 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 - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254314 CERAMIC ELECTRODE TIP J-HK F/GK372R REUSABLE INSTRUMENTS GEI AESCULAP AG GK383R

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention