BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 6058924 · Received October 26, 2016

    Report

    Report Number
    0001055892-2016-00005
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 25, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SYNERGY HEALTH
    Product Code
    OCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL COMPLAINT STATED INSULATION WAS FOUND IN LUMEN OF DEVICE AFTER SURGERY. BASED ON THE ADDITIONALLY OBTAINED INFORMATION ON 10/25/2016 AT 3:16PM FROM (B)(6), THERE WAS NO DELAY OF SURGERY OR ADVERSE EVENT OCCURRED. LAPAROSCOPIC INSULATION WAS FOUND AFTER SURGERY AND NOT PRESENT DURING SURGERY. NO DETAILS WERE RECORDED OR MAINTAINED BY REX HEALTHCARE.

    Description of Event or Problem · 1

    LAPAROSCOPIC INSULATION FOUND INSIDE MONOPOLAR SUCTION / IRRIGATION POLE. NO DELAY TO PROCEDURE. EVENT DID NOT CAUSE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709800 STRYKER MONOPOLAR SUCTION / IRRIGATION POLE OCX SYNERGY HEALTH 250-070-443

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention