BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RP 360° FLEXIBLE NEEDLE

    MDR report key: 7080920 · Received December 4, 2017

    Report

    Report Number
    3004086872-2017-00012
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 4, 2017
    Manufacturer
    COORSTEK MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW SHOWS NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURE LOT OF NEEDLES. REVIEW ALSO SHOWS THAT SAMPLE NEEDLES FROM THIS LOT WERE FATIGUE TESTED SHOWING WITH 95% CONFIDENCE THAT 99.9% OF THE LOT WOULD PASS A MINIMUM OF 24 CYCLES. DATE PRODUCT RECEIVED: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DEVICE IDENTIFICATION: 3910-900-091/H. VISUAL INSPECTION: WHERE THE PRODUCT WAS NOT RETURNED A VISUAL INSPECTION WAS NOT PERFORMED. FUNCTIONAL INSPECTION: WHERE THE PRODUCT WAS NOT RETURNED A FUNCTIONAL INSPECTION WAS NOT PERFORMED. THIS IS A KNOWN FAILURE MODE ADDRESSED IN THE RISK MANAGEMENT FILE FOR THIS PRODUCT, AND DOES NOT EXCEED EXPECTED OCCURRENCE RATES. OCCURRENCE RATES ARE MONITORED FOR TRENDS. SERVICE HISTORY REVIEW: THERE HAS BEEN NO SERVICE ON THIS DEVICE. MANUFACTURING DATE: 12-21-2015. ROOT CAUSE(S): WHERE THE DEVICE WAS NOT RETURNED AND THE DESCRIPTION OF THE COMPLAINT DOES NOT CONTAIN ENOUGH INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED. MANUFACTURER ERROR: THERE IS NOTHING IN THE DESCRIPTION OF THE COMPLAINT AND THERE WAS NOTHING FOUND IN THE REVIEW OF THE DEVICE HISTORY RECORD THAT WOULD INDICATE THIS IS A RESULT OF A MANUFACTURING ERROR. COUNTRY OF EVENT: USA.

    Description of Event or Problem · 1

    RP 360 NEEDLE TIP BROKE WHEN BEING USED WITH THE CHAMPION SUTURE PASSER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860309 RP 360° FLEXIBLE NEEDLE SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 1001972

    Patients

    Seq Age Sex Outcome Treatment
    1