BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE RING WITH NEEDLE

    MDR report key: 15699198 · Received October 31, 2022

    Report

    Report Number
    9610612-2022-00328
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 6, 2022
    Report Date
    October 12, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    GDG
    PMA / PMN Number
    EXEMPT
    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/CORRECTION: H6 - CODES UPDATED UPON REVIEW OF INVESTIGATION, PRODUCT RISK ANALYSIS WAS ALSO ADJUSTED. THIS COMPLAINT WAS RE-ASSESSED AND NO LONGER FOUND TO BE REPORTABLE; SEVERITY IS NOW DECREASED TO1(5). INVESTIGATION RESULTS: WE HAVE HAD THE PRODUCT ANALYSIS IN THE PRODUCTION PLANT VIA THE Q-COORDINATOR. SILICONE RING IS OBVIOUSLY CRACKED. DEVICE HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE ACCORDING TO PROCEDURES: SEVERITY WAS 1(5) AND PROBABILITY 1(5). CONCLUSION AND PREVENTIVE MEASURES: WITH THE AVAILABLE MEANS, NO FEATURES ARE VISIBLE ON THE PRESENT SILICONE RING THAT WOULD EXPLAIN THE CRACKING. A VISUAL INSPECTION IN PRODUCTION DID NOT REVEAL ANY INDICATIONS OF A POSSIBLE CAUSE. THE CHECKED HFW COMPONENTS DID NOT SHOW ANY ABNORMALITY. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    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: PATIENT HARM WAS CONFIRMED AS "NONE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL595SU - SILICONE RING WITH NEEDLE. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING SURGERY, THE SILICONE RING WAS TORN IMMEDIATELY AFTER USE. PATIENT HARM WAS UNKNOWN. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419032 SILICONE RING WITH NEEDLE HANDHELD PRODUCTS & LIGATION GDG AESCULAP AG PL595SU 52753015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown