BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEALING CAP FOR 5MM TROCARS

    MDR report key: 6914162 · Received October 4, 2017

    Report

    Report Number
    9610612-2017-00481
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 14, 2017
    Report Date
    June 23, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    OKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H10: SHOULD READ. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. AFTER AN OPERATION, THE CUSTOMER FOUND THAT THE VALVE WAS DAMAGED. APPROX. 5MM OF SLIT WAS MISSING. THE CUSTOMER COULD NOT FIND ANY FAILURES, SUCH AS AIR LEAKAGE OR THE FRAGMENT WENT INSIDE PATIENT DURING PROCEDURE. THE CONDITION OF THE PRODUCT AT THE INSPECTION BEFORE THE OPERATION IS UNKNOWN. THEREFORE, THERE IS THE POSSIBILITY THE FRAGMENT REMAINS INSIDE PATIENT. THE CUSTOMER CONCERNS THE RISK FOR PATIENT IF THE FRAGMENT WOULD REMAIN. ALL MED WATCH SUBMISSIONS TO THIS REPORT ARE: 9610612-2017-00481. 9610612-2017-00482.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING; RESULTS WILL BE PROVIDED, IF AVAILABLE.

    Description of Event or Problem · 1

    AFTER AN OPERATION, THE CUSTOMER FOUND THAT THE VALVE WAS DAMAGED. APPROXIMATELY 5 MM OF SLIT WAS MISSING. THE CUSTOMER HAD NOT FOUND ANY FAILURES, SUCH AS AIR LEAKAGE; OR THE FRAGMENT WENT INSIDE PATIENT DURING PROCEDURE. THE CONDITION OF THE PRODUCT AT THE INSPECTION BEFORE THE OPERATION IS UNKNOWN. THEREFORE, THERE IS THE POSSIBILITY THE FRAGMENT REMAINS INSIDE PATIENT. ASSOCIATED MED WATCH SUBMISSIONS: 9610612-2017-00481, 9610612-2017-00482.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694334 SEALING CAP FOR 5MM TROCARS ENDOSCOPY OKX AESCULAP AG EK082P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other