BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE

    MDR report key: 1707199 · Received May 27, 2010

    Report

    Report Number
    3004365956-2010-00058
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Report Date
    April 30, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: NO LOT NUMBER AND NO PRODUCT NUMBER WAS PROVIDED, BASED ON THIS, NO DEVICE HISTORY REVIEW CAN BE PERFORMED AT THIS TIME. REVIEW OF IN-COMING INSPECTION RECORDS PERFORMED. RESULTS: NO RESULTS CAN BE DEFINED. NO NCMR FOR NEEDLE BREAKAGE WERE FOUND FROM RECORDS OF 2009 THROUGH 2010, ALSO, INCOMING INSPECTION RECORDS WERE REVIEWED TO VERIFY THAT THE FOLLOWING NEEDLES (143601, 143609, 155317) DO NOT PRESENT ANY KIND OF DAMAGE THAT CAN BE ATTRIBUTED TO COMPLAINT DESCRIPTION, FINDING THAT ALL OF THEM WERE IN COMPLIANCE ACCORDING TO MANUFACTURER'S SPECIFICATIONS. CONCLUSIONS: NO ROOT CAUSE CAN BE ESTABLISHED DUE TO LACK OF INFO ABOUT THE PRODUCT CODE AND LOT NUMBER TO PERFORM AN INVESTIGATION. NO SAMPLE AVAILABLE FOR EVALUATION. IF A LOT NUMBER AND PRODUCT NUMBER BECOMES AVAILABLE AT A LATER DATE, THIS INVESTIGATION WILL BE RE-OPENED ACCORDINGLY.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A PROCEDURE, THE SURGEON THREW THE CAPIO DEVICE AND NOTICED THE NEEDLE TIP HAD DETACHED AND WAS IMBEDDED IN THE SACROSPINOUS LIGAMENT. THE NEEDLE TIP WAS LEFT IN THE PT. NO REPORTED INJURY TO THE PT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE CAPIO SUTURE GAO TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1