BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEALING UNIT F/10/12MM TROCARS W.REDUCER

    MDR report key: 14365860 · Received May 11, 2022

    Report

    Report Number
    9610612-2022-00120
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    March 14, 2022
    Report Date
    July 20, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    FBQ
    UDI-DI
    04046963417710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED: B5 - CLARIFICATION OF EVENT INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BASED UPON THE PROVIDED PICTURE, IT COULD BE DETECTED THAT THE SEALING OF THE COMPLAINT SAMPLE WAS TORN AND THE CROSS SLOT VALVE 10-12 MM WAS FOUND IN SITU. BATCH HISTORY REVIEW DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. EXPLANATION AND RATIONALE: ACCORDING TO THE APPLICABLE INSTRUCTIONS FOR USE (IFU), THE FOLLOWING POINTS MUST BE OBSERVED: ->TO PREVENT DAMAGE TO THE SEALING ELEMENT, APPLY APPROPRIATE CARE WHEN INSERTING ANY INSTRUMENTS -> IF POSSIBLE, INSERT INSTRUMENTS IN THEIR CLOSED POSITION, STRAIGHT AND CENTRAL THROUGH THE SEALING ELEMENT CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP AG THAT A SEALING UNIT F/10/12MM TROCARS W.REDUCER (PART # EK083P) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE INTERNAL PORT FELL OUT INTO THE PATIENT. IT WAS NOTED THAT EVEN AFTER "WETTING" THE APPLIERS (NON-AESCULAP PRODUCT: LARGE ENDOSCOPIC LIGATING CLIP APPLIERS), THE DEVICE DID NOT GO SMOOTHLY IN AND OUT OF THE 12 MILLIMETER (MM) PORT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). .

    Description of Event or Problem · 0

    CLARIFICATION: IT WAS CONFIRMED THAT ALL PIECES WERE RETRIEVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130895 SEALING UNIT F/10/12MM TROCARS W.REDUCER ACCESS / TROCARS FBQ AESCULAP AG EK083P 04046963417710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention