BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY NEEDLE KIT, PASSIVE

    MDR report key: 1943933 · Received December 1, 2010

    Report

    Report Number
    1723170-2010-00113
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER WAS NOT RELEASED BY THE HOSP. THE DEVICE WAS DISCARDED AT THE HOSP. NO NEEDLES WERE AVAILABLE TO SEND IN FOR INVESTIGATION. TECHNICAL SERVICES PROVIDED ADD'L INSTRUCTIONS ON INSTRUMENT OPERATION TO THE MEDTRONIC REP WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REP WHO WAS ON-SITE, REPORTED THAT THE PASSIVE BIOPSY NEEDLE, USED WITH THE STEALTHSTATION S7 SYSTEM, NEEDLE WAS TRACKING RED/GREEN STATUS. CASE WAS CONTINUED. DIAGNOSTIC TISSUE WAS TAKEN DURING THE BIOPSY. THERE WAS NO IMPACT ON PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY NEEDLE KIT, PASSIVE STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION NA 066122509

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR STEALTHSTATION S7 SYSTEM