BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN AESCULAP AG KNIFE HANDLE

    MDR report key: 23782838 · Received December 11, 2025

    Report

    Report Number
    9610612-2025-00293
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Report Date
    December 29, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    GDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS NOT MADE AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: BASED ON THE COMPLAINT INFORMATION AVAILABLE NEITHER THE ARTICLE NUMBER NOR THE LOT NUMBER COULD BE IDENTIFIED. ALSO, AFTER MEANINGFUL ATTEMPTS NO FURTHER INFORMATION COULD BE RECEIVED. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: MW5178606. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: - NO DEATH OR SERIOUS INJURY. - NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. 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

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN UNKNOWN AESCULAP AG KNIFE HANDLE VIA INFORMATION RECEIVED FROM MW5178606. ACCORDING TO THE COMPLAINT DESCRIPTION, THE KNIFE HANDLE BROKE OFF. THERE WAS NO REPORTED PATIENT HARM. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: MW5178606. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: NO DEATH OR SERIOUS INJURY. NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625652 UNKNOWN AESCULAP AG KNIFE HANDLE GENERAL SURGICAL INSTRUMENTS GDZ AESCULAP AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown