BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RP 360 SUTURE PASSER NEEDLE

    MDR report key: 6537925 · Received May 2, 2017

    Report

    Report Number
    3004086872-2017-00004
    Event Type
    Malfunction
    Date Received
    May 2, 2017
    Date of Event
    April 10, 2017
    Report Date
    June 14, 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

    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: REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS MANUFACTURE LOT OF NEEDLES WAS FATIGUE TESTED SHOWING WITH 95% CONFIDENCE THAT 100% OF THE LOT WOULD PASS A MINIMUM OF 24 CYCLES. THERE WERE ALSO NO MANUFACTURING NON-CONFORMANCES NOTED IN THE DEVICE HISTORY RECORD. IT WAS REPORTED THE CUFF WAS OF NORMAL THICKNESS. THEY SAW THE TIP BUT LOST IT BEFORE THEY WERE ABLE TO REMOVE IT FROM THE PATIENT. THE TYPE OF SUTURE USED IS UNKNOWN. WHERE THE PRODUCT WAS NOT RETURNED AN EXACT ROOT CAUSE COULD NOT BE DETERMINED BUT REVIEW OF THE DEVICE HISTORY RECORD SHOWS THE PROBABILITY OF THIS BEING A MANUFACTURING ERROR IS LOW DUE TO THE CONFIDENCE LEVEL IN THE FATIGUE TESTING PERFORMED. SERVICE HISTORY REVIEW: THERE HAS BEEN NO SERVICE ON THIS DEVICE. COUNTRY OF EVENT: (B)(6). PRODUCT HAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A FOLLOW UP TO THE INITIAL REPORT (3004086872-2017-00004), FOLLOWING THE RETURN AND EVALUATION OF THE COMPLAINT SAMPLE. THE RETURNED NEEDLE WAS VISUALLY EVALUATED AND COMPARED TO A NEEDLE THAT HAD BEEN CYCLED THROUGH REPETITIVE CYCLES IN A SUTURE PASSER. IT WAS NOTICED THE BEND RADIUS OF THE BROKEN NEEDLE HAD FLAT SECTIONS AND MORE OF AN ABRUPT BEND IN ONE AREA. THE MAY INDICATED THE TIP OF THE NEEDLE CAME IN CONTACT WITH SOMETHING HARD CAUSING THE NEEDLE TO DEVIATE FROM THE NORMAL BEND RADIUS. THERE WAS NO EVIDENCE THAT SHOWED THE NEEDLE BREAKAGE MAY HAVE BEEN A RESULT OF A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    CUSTOMER MRS (B)(6) CALLED TO SALES REP MRS (B)(6) AND INFORMED THAT WHEN THEY USE 3910-900-089 CHAMPION SUTURE PASSER RATCHET HUMPBACK CAPTURE (RHC) NEEDLE 3910-900-091 LOT 947583 CHAMPION SUTURE PASSER FLEXIBLE NEEDLE BROKE FROM THE TIP. SHE SAID IT WORKED 2-3 TIMES NORMALLY AND AFTER THAT IT DID NOT WENT THROUGH AND DID NOT CAPTURE THE SUTURE. NEEDLE WILL BE SEND TO FINNISH CUSTOMER SERVICE.

    Description of Event or Problem · 1

    CUSTOMER MRS (B)(6) CALLED TO SALES REP MRS (B)(6) AND INFORMED THAT WHEN THEY USE 3910-900-089 CHAMPION SUTURE PASSER RATCHET HUMPBACK CAPTURE (RHC) NEEDLE 3910-900-091 LOT 947583 CHAMPION SUTURE PASSER FLEXIBLE NEEDLE BROKE FROM THE TIP. SHE SAID IT WORKED 2-3 TIMES NORMALLY AND AFTER THAT IT DID NOT WENT THROUGH AND DID NOT CAPTURE THE SUTURE. NEEDLE WILL BE SEND TO FINNISH CUSTOMER SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318868 RP 360 SUTURE PASSER NEEDLE SUTUER PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 847583

    Patients

    Seq Age Sex Outcome Treatment
    1