BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSURGICAL

    MDR report key: 6875407 · Received September 19, 2017

    Report

    Report Number
    1319447-2017-00001
    Event Type
    Injury
    Date Received
    September 19, 2017
    Report Date
    September 7, 2017
    Manufacturer
    INTERSURGICAL INC
    Product Code
    BZE
    PMA / PMN Number
    K092129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIZE OF T-PIECE 7.6MM PORT, WHERE THE T-PROBE IS INSERTED, IS CHECKED DURING QC CHECKS AT MOULDING. WE HAVE GAUGED THE RETURNED SAMPLE AND FOUND IT TO MEET REQUIREMENTS. THE T-PROBE AND T-PIECE WERE CONDITIONED AND A AXIAL SEPARATION FORCE WAS APPLIED AND THE T-PROBE DID NOT DETACH. THE PULL OFF FORCE WAS MEASURED SEPARATELY AND IT WAS WITHIN SPECIFICATION. THE SECURITY OF ENGAGEMENT WAS FOUND TO MEET REQUIREMENTS.

    Description of Event or Problem · 1

    THE PRODUCT CAN BECOME LOOSE AND/ OR FALL OUT AND RESULT IN LESS TIDAL VOLUME DELIVERED TO PATIENT. THERE WERE NO SPECIFIC INJURIES ATTRIBUTED TO THE DISLODGEMENT OF THE TEMPERATURE PROBES. THE TEMPERATURE PROBES WERE RE-SEATED TO SEAL THE LEAK WHEN AN INCIDENT WOULD OCCUR AND WOULD BE CHECKED PERIODICALLY TO ENSURE TIGHTNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655457 INTERSURGICAL HEATED WIRE BREATHING CIRCUIT WITH AUTO-FILL CHAMBER BZE INTERSURGICAL INC 2026031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other