BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG, FLOWPORT II ADAPTER, STRYKER

    MDR report key: 10276362 · Received July 15, 2020

    Report

    Report Number
    0002936485-2020-00276
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 15, 2020
    Report Date
    October 1, 2020
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    UDI-DI
    07613252632917
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: LEAKING ADAPTOR. PROBABLE ROOT CAUSE: DESIGN: POOR INTERCONNECTION DESIGN. MANUFACTURING: ADAPTER OR CANNULA NOT MANUFACTURED TO SPECIFICATION. APPLICATION: USER ERROR - CANNULA/ADAPTER NOT CONNECTED PROPERLY. IMPROPER HANDLING CAUSES DAMAGE TO CANNULA/ADAPTER. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN. THE INVESTIGATION WAS PREVIOUSLY CLOSED BASED ON PRODUCT NOT RECEIVED; HOWEVER, THE PRODUCT HAS NOW BEEN PHYSICALLY RECEIVED AT STRYKER ENDOSCOPY, USA AND THE INVESTIGATION HAS BEEN RE-OPENED. INVESTIGATION AS FOLLOWS IS NOW BASED ON PRODUCT RECEIVED. ALLEGED FAILURE: AS REPORTED: "BOTH ADAPTERS IN BIRMINGHAM TEAM¿S INVENTORY ARE MISSING INTERNAL SUCTION RING CAUSING THE FLOWPORT ADAPTER TO LEAK AND SPRAY WATER ALL OVER SURGEON". THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE: 1) INAPPROPRIATE DISASSEMBLY OF DEVICE DURING REPROCESSING, 2) ROUGH HANDLING OF DEVICE DURING REPROCESSING, OR 3) EXCESSIVE FORCE APPLIED ON DEVICE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS INCREASED TRACTION TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS INCREASED TRACTION TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738963 FG, FLOWPORT II ADAPTER, STRYKER ACCESSORIES, ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE N/A 07613252632917

    Patients

    Seq Age Sex Outcome Treatment
    1