BEUDAMED
    FDA Adverse Event Other Summary report: N

    E8C ENDOCAVITY NEEDLE

    MDR report key: 2396654 · Received December 22, 2011

    Report

    Report Number
    1937223-2011-00001
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    November 16, 2011
    Report Date
    December 22, 2011
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    ITX
    PMA / PMN Number
    K970514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CIVCO NOTIFIED OF THE EVENT BY (B)(4) ON (B)(4) 2011. RESULT: LACERATION. CONCLUSION: NO EVALUATION WILL BE PERFORMED. NARRATIVE: METHOD: DEVICE NOT AVAILABLE FOR EVALUATION. SAMPLES FROM THE SAME LOT WERE REVIEWED ALONG WITH DEVICE INSPECTION AND APPROVAL RECORDS. RESULT: PATIENT RECEIVED A LACERATION WHICH REQUIRED A SUTURE TO CONTROL BLEEDING. CONCLUSION: DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE INSPECTION RECORDS SHOW THE LOT OF NEEDLE GUIDES PASSED ALL INSPECTION CRITERIA. THE DEVICE HAS A HIGH PROFILE WHICH IS REQUIRED TO FOLLOW THE ULTRASOUND SOFTWARE NEEDLE PATH ESTABLISHED BY THE OEM TRANSDUCER MANUFACTURER.

    Description of Event or Problem · 1

    CIVCO WAS NOTIFIED OF THIS OCCURRENCE ON (B)(4) 2011 BY (B)(4). EVENT DESCRIPTION: PATIENT RECEIVED A LACERATION TO HER HYMEN THAT REQUIRED A SUTURE TO CONTROL BLEEDING. THE TEAR OCCURRED UPON ENTRY OF THE NEEDLE GUIDE INTO THE PATIENT. PHYSICIAN FELT THAT THE SHAPE OF THE NEEDLE GUIDE WAS A CONTRIBUTING FACTOR TO THE TEAR AND CHOSE NOT TO USE IT FURTHER. FACILITY NOTED THAT THE NEEDLE GUIDE IS SUPPLIED BY CARDINAL HEALTH IN A CUSTOM PACKAGE AND WAS NOT THE NEEDLE GUIDE THEY HAD REQUESTED FOR USE IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E8C ENDOCAVITY NEEDLE DISPOSABLE ENDOCAVITY NEEDLE GUIDE ITX CIVCO MEDICAL INSTRUMENTS CO., INC. 742-306 M75570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention