BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I

    MDR report key: 8456914 · Received March 27, 2019

    Report

    Report Number
    3004365956-2019-00067
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    February 21, 2019
    Report Date
    March 4, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS ISSUED FOR THE FOLLOWING LOT NUMBERS: THE LOT NUMBER 74E1700236 (N/P: 833-113), 74F1700809 (N/P: 833-123) & 74E1800414 (N/P: 833-137LP). FOR BATCHES 74E1700236 AND 74F1700809 NO ISSUES OR DISCREPANCIES WERE FOUND THAT CAN BE RELATED TO THE FAILURE MODE REPORTED IN THE CUSTOMER COMPLAINT. FOR LOT NUMBER 74E1800414 A NONCONFORMANCE WAS ISSUED FOR ANOTHER CONDITION THAT IS NOT RELATED TO THE FAILURE MODE REPORTED. NO CORRECTIVE ACTION CAN BE IMPLEMENTED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAPIO WAS FIRED TO PLACE THE SUTURE INTO THE SACROSPINOUS LIGAMENT BUT THE DART AT THE END OF THE SUTURE CAME OFF AND LODGED INTO THE PATIENT'S LIGAMENT. THE CASE WAS COMPLETED USING THE DEVICE WITH NO PATIENT COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF A PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAPIO WAS FIRED TO PLACE THE SUTURE INTO THE SACROSPINOUS LIGAMENT BUT THE DART AT THE END OF THE SUTURE CAME OFF AND LODGED INTO THE PATIENT'S LIGAMENT. THE CASE WAS COMPLETED USING THE DEVICE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248205 COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I GAT TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1