BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE PASSER

    MDR report key: 6518620 · Received April 25, 2017

    Report

    Report Number
    3004086872-2017-00003
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    March 30, 2017
    Report Date
    June 14, 2017
    Manufacturer
    COORSTEK MEDICAL
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: WHERE PRODUCT HAS NOT RETURNED, A VISUAL INSPECTION WAS NOT PERFORMED. FUNCTIONAL INSPECTION: WHERE PRODUCT HAS NOT RETURNED, A FUNCTIONAL INSPECTION WAS NOT PERFORMED. ADDITIONAL INVESTIGATION NOTES: WHERE THE PRODUCT HAS NOT RETURNED, THE INVESTIGATION WILL BE LIMITED TO COMMENTS IN THE COMPLAINT AND A REVIEW OF RECORDS. THERE ARE NOT ENOUGH DETAILS IN THE DESCRIPTION OF THE COMPLAINT TO DETERMINE A ROOT CAUSE. DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES WITH THIS MANUFACTURE LOT. SAMPLE NEEDLES FROM THIS LOT WERE FATIGUE TESTED SHOWING WITH 95% CONFIDENCE THAT 99.9% OF THE LOT WOULD MEET THE 24 CYCLE MINIMUM. SERVICE HISTORY REVIEW: THERE HAS BEEN NO SERVICE ON THIS DEVICE. COUNTRY OF EVENT: (B)(6). DEVICE HAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A FOLLOW UP TO THE INITIAL REPORT (3004086872-2017-00003), FOLLOWING THE RETURN AND EVALUATION OF THE COMPLAINT SAMPLE. THE RETURNED NEEDLE WAS VISUALLY INSPECTED AND IT WAS NOTICED THE BEND IN THE NEEDLE DID NOT FOLLOW THE NATURAL BEND OF A NEEDLE THAT HAS BEEN CYCLED THROUGH A SUTURE PASSER. THIS COULD POSSIBLY INDICATE THE NEEDLE WAS BROKEN PRIOR TO INSERTING IT IN THE SUTURE PASSER OR THE NEEDLE CAME IN CONTACT WITH SOMETHING HARD WHICH CAUSED THE BEND IN THE NEEDLE TO DEVIATE FROM THE NORMAL BEND RADIUS. THERE WAS NO EVIDENCE OF A NON-CONFORMANCE DUE TO A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    ALLEGED PROBLEM(S): THE TIP OF THE REF 3910-900-091 NEEDLE OF THE CHAMPION CLAMP REF 3910-900-088 BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED SHOWED NO ADVERSE EVENTS BUT THE TIP OF THE NEEDLE WAS LEFT IN THE SURGICAL SITE. PRODUCT WAS ORIGINALLY DUE TO RETURN BUT HAS NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGED PROBLEM(S): THE TIP OF THE REF 3910-900-091 NEEDLE OF THE CHAMPION CLAMP REF 3910-900-088 BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED SHOWED NO ADVERSE EVENTS BUT THE TIP OF THE NEEDLE WAS LEFT IN THE SURGICAL SITE. PRODUCT WAS ORIGINALLY DUE TO RETURN BUT HAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301642 SUTURE PASSER SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 1203063

    Patients

    Seq Age Sex Outcome Treatment
    1