BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE PASSER NEEDLE

    MDR report key: 9538206 · Received January 2, 2020

    Report

    Report Number
    3004086872-2019-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    November 19, 2019
    Report Date
    December 4, 2019
    Manufacturer
    COORSTEK MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IDENTIFICATION:3910-900-091 ; LOT# 1415027. DEVICE HISTORY RECORD REVIEW: : DEVICE HISTORY RECORD REVIEW SHOWS NO NON-CONFORMANCES ASSOCIATED WITH THIS MANUFACTURE LOT. ADDITIONAL REVIEW SHOWS FATIGUE TESTING OF SAMPLE NEEDLES FROM THIS LOT CONFIRM WITH 95% CONFIDENCE THAT 99.9% OF THE NEEDLES IN LOT 1415027 WILL PASS A MINIMUM OF 24 CYCLES. VISUAL INSPECTION: VISUAL INSPECTION OF THE DEVICE SHOWS SOME SLIGHT BENDING IN THE NEEDLE BLADE CONSISTENT WITH THE BLADE COMING IN CONTACT WITH SOMETHING HARD OR PASSING THROUGH TOUGHER TISSUE. IN A COMPARSION WITH A UNBROKEN NEEDLE CYCLED THROUGH A SUTURE PASSER, SIDE BY SIDE, THE NEEDLE IS CONFIRMED TO HAVE A BEND. FUNCTIONAL INSPECTION: WHERE THE RETURNED NEEDLE WAS ALREADY BROKEN A FUNCTIONAL INSPECTION WAS NOT DONE. ROOT CAUSE(S): THE STATEMENT IN THE ALLEGED PROBLEM," THE DOCTOR TRY MANU TIMES UNTOS THE NAIL BROKE" AND VISUAL INSPECTION OF THE DEVICE SHOWS SOME SLIGHT BENDING IN THE NEEDLE BLADE CONSISTENT WITH THE BLADE COMING IN CONTACT WITH SOMETHING HARD OR PASSING THROUGH TOUGHER TISSUE WHICH HAVE CAUSED THE NEEDLE TO BEND THEN BREAK. 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 IN THIS PRODUCT. THE COUNTRY OF ORIGIN IS (B)(6).

    Description of Event or Problem · 1

    THE CHAMPION SUTURE PASSER DOESN'T PASS THE TISSUE, THE DOCTOR TRY MANY TIMES UNTOS THE NEEDLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214 SUTURE PASSER NEEDLE SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 1415027

    Patients

    Seq Age Sex Outcome Treatment
    1