BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4162646 · Received July 16, 2014

    Report

    Report Number
    2134070-2014-00135
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K121240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH A SMALL CHIP ON THE DISTAL END OF THE SLEEVE TIP. THERE WERE NO INDICATIONS OF PATIENT CONTACT. IT WAS NOT CLEAR IF THE DEVICE WAS SENT OUT IN THIS CONDITION. UPON EVALUATION, THE DEVICE PASSED FUNCTION TESTING, INCLUDING A PRESSURE TEST BOTH WITH AND WITHOUT THE OBTURATOR INSERTED INTO THE SLEEVE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOT ASSISTED EXPLORATORY EXCISION PELVIC MASS A 5MM SCOPE WAS ADVANCED DOWN THE DEVICE - AT THE VERY TIP THE DEVICE APPEARED CHIPPED. THE DEVICE WAS BELIEVED TO BE USED ON THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ALTERATION IN THE OUTCOME, AND NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417155 NA NLM - ENDOSCOPIC TROCAR NLM STERILMED, INC. ETH2B5LT 1761502

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR