BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE PASSER NEEDLE

    MDR report key: 6919404 · Received October 6, 2017

    Report

    Report Number
    3004086872-2017-00008
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 7, 2017
    Report Date
    October 3, 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: DEVICE HISTORY RECORD REVIEW SHOW NO NON-CONFORMANCES WITH THIS MANUFACTURE LOT. FATIGUE TESTING OF NEEDLES FROM THIS MANUFACTURE LOT SHOWS WITH 95% CONFIDENCE THAT 99.9% OF THE LOT WOULD PASS A MINIMUM OF 24 CYCLES. THE INSTRUCTIONS FOR USE INCLUDED WITH THE PRODUCT CAUTION AGAINST THE USE OF DIRECT FORCE AND INSTRUCT THE USER TO USE THE PRODUCT UNDER DIRECT VISUALIZATION. DATE PRODUCT RECEIVED: PRODUCT WAS NOT RETURNED. DEVICE IDENTIFICATION: 3910-900-091. VISUAL INSPECTION: WHERE PRODUCT WAS NOT RETURNED A VISUAL INSPECTION WAS NOT PERFORMED. FUNCTIONAL INSPECTION: WHERE 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. ROOT CAUSE(S): WHERE THE PRODUCT WAS NOT RETURNED AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES COULD BE USER RELATED SUCH AS THE NEEDLE CONTACTING SOMETHING HARD LIKE BONE. MANUFACTURER ERROR: WITH LIMITED INFORMATION THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE IS NOTHING IN THE RECORD THAT WOULD ATTRIBUTE THIS TO AN ERROR IN MANUFACTURING.

    Description of Event or Problem · 1

    CHAMPION SUTURE PASSER NEEDLE BROKE DURING CASE. COUNTRY OF EVENT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701980 SUTURE PASSER NEEDLE SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 1203063

    Patients

    Seq Age Sex Outcome Treatment
    1