BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP.BALLOON TROCAR HASSON CONE 12/100MM

    MDR report key: 23716225 · Received December 4, 2025

    Report

    Report Number
    9610612-2025-00292
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 19, 2025
    Report Date
    April 1, 2026
    Manufacturer
    AESCULAP AG
    Product Code
    OKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9 - DEVICE RETURN. H3 - YES, DEVICE EVALUATED. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED MEDICAL DEVICE WAS MADE AVAILABLE FOR INVESTIGATION. DURING VISUAL INSPECTION, THE BALLOON COULD NOT BE INFLATED WITH THE SUPPLIED SYRINGE. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS, VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST THE AFFECTED BATCH NUMBER. CONCLUSION/ PREVENTIVE MEASURES: THE ERROR PATTERN COULD BE CONFIRMED. THE EXACT ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. THE FAILURE MODE OBSERVED IS CONSISTENT WITH THERMAL DEFORMATION BEHAVIOR IDENTIFIED IN SIMULATION TESTING. HOWEVER, NO DIRECT EVIDENCE INDICATES THAT SUCH EXPOSURE OCCURRED DURING STORAGE OR USE, AND THE CUSTOMER CONFIRMED NO EXPOSURE TO ELEVATED TEMPERATURE. ALL RETAINED SAMPLES AND PRODUCTION RECORDS CONFIRMED NORMAL PRODUCT PERFORMANCE, AND NO SIMILAR CASES WERE IDENTIFIED WITHIN THE SAME BATCH. THE ISSUE IS THEREFORE CONSIDERED AN ISOLATED CASE. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. BASED UPON INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED. FINAL COMMENTS: 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 THE REVIEW OF THE APPLICABLE RISK ANALYSIS.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS A SIMILAR DEVICE REPORT, A SIMILAR DEVICE OF THE REPORTED DEVICE WAS SOLD TO US; THE REPORTED DEVICE IS NOT MARKETED IN THE US.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH EK517SU - DISP.BALLOON TROCAR HASSON CONE 12/100MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BALLOON FAILED TO INFLATE INTRAOPERATIVELY. THERE WAS NO ADVERSE CONSEQUENCE FOR PATIENT REPORTED. 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 THE REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2807765 DISP.BALLOON TROCAR HASSON CONE 12/100MM DISPOSABLE TROCARS OKX AESCULAP AG EK517SU 6052309028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown