BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE GUIDE

    MDR report key: 14644326 · Received June 9, 2022

    Report

    Report Number
    1937233-2022-00001
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 7, 2022
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    ITX
    UDI-DI
    00841436114219
    PMA / PMN Number
    K875240
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CIVCO RECEIVED A REPORT OF OUR NEEDLE GUIDE DETACHING DURING A PROCEEDURE AND CAUSING A LACERATION TO THE VAGINAL WALL OF A PATIENT. THE DISTRIBUTOR RECEIVED THE REPORT FROM THE USER FACILITY ON (B)(6) 2022, HOWEVER CIVCO DID NOT BECOME AWARE OF THE REPORTING UNTIL 5/10/2022. THE REPORT STATED THAT THE GUIDE BECAME DETACHED DURING A PROCEDURE CAUSING THE PATIENT PAIN. THE RESULT WAS A LACERATION TO THE VAGINAL WALL WHICH REQUIRED 1 STICH TO TREAT. FUTHER COMMUNICATIONS SHARED DISCLOSED THIS HAPPENED DURING AN IVF PROCEEDURE WITH THE NEEDLE GUIDE. THE DOCTOR SHARED THAT THEY HAVE ENCOUNTERED THE GUIDE CAN DISCONNECT FROM THE PROBE WHEN THERE ARE 40-50 FOLICLES BUT WORKS WELL IF THERE ARE ONLY 10-12. THIS COULD INDICATE MORE FORCE IS EXERTED ON THE PROBE AND NEEDEL GUIDE WHEN POSITIONING IN THIS ENVIRONMENT THAN WHAT THE PROBE WAS INTENDED TO ENCOUNTER. THE USE OF THE GUIDE FOR IVF PROCEEDURES IS AN OFF LABEL USE. EVALUATIONS OF THE NEEDLE GUIDES RETURNED BY THE USER FACILITY IDENTIFIED THE HOLDING FORCE OF THE NEEDLE GUIDE TO TEST PROBES IN HOUSE HAVE THE SAME HOLDING FORCE AS THE POPULATION OF GUIDES DID AT THE INTIAL RELEASE OF THE PRODUCT LINE. FURTHER, THERE WERE NO SHARP EDGES FOUND ON THE NEEDLE GUIDES WHICH WOULD INDICATE ANY MANUFACTURING DEFECT. CIVCO'S CONCLUSION IS THAT THERE WAS NOT A PRODUCT FAILURE ASSOCIATED WITH THE DESIGN AND THE PRODUCT DID NOT MALFUNCTION IN USE. THE FOUR GUIDES WHICH WERE RETURNED FOR EVALUATION ARE IDENTIFIED BY SERIAL NUMBERS: (B)(4). THESE GUIDES WERE MANUFACTURED IN NOVEMBER 2021. THE DISTRIBUTOR OF THE DEVICE (GWHC) HAS ALSO CONDUCTED AN INCIDENT REPORT ASSOCIATED WITH THIS GUIDE IN CORRELATION TO THEIR EVALUATION OF THE USE WITH THEIR SYSTEM PROBE. THE ASSOCIATED MANUFACTURER INCIDENT REPORT FOR THIS IS (B)(4).

    Description of Event or Problem · 0

    CIVCO RECEIVED A COMPLAINT FROM OUR DISTRIBUTOR ON (B)(6) 2022 THAT A REUSABLE ENDOCAVITY NEEDLE GUIDE DID NOT STAY ATTACHED TO THE PROBE DURING USAGE AND CAUSED A LACERATION TO THE VAGINAL WALL REQUIRING A STICH TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027261 NEEDLE GUIDE TRANSVAGINAL NEEDLE / BIOPSY BUIDE ITX CIVCO MEDICAL INSTRUMENTS CO., INC. H46721R 00841436114219

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention