BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCOPE, REVERSE LIGHTPOST, 2.9MM, 30 DEG

    MDR report key: 3233626 · Received July 18, 2013

    Report

    Report Number
    1220246-2013-00124
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K030096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. TYPICALLY, A BENT SHAFT IS CAUSED BY PRYING/LEVERAGING THE DEVICE DURING USE WHEN IT IS NOT PROPERLY INSERTED INTO THE GUIDE SHEATH AND/OR MISHANDLING. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/SERIAL NUMBER COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTERLINE SYSTEM WAS PUT INTO THE CANAL VIA THE NORMAL TECHNIQUE APPROACH, THEN WAS ABORTED WHEN THE SURGEON FELT HE WAS UNABLE TO PERFORM THE PROCEDURE IN A SAFE MANNER DUE TO LACK OF VISUALIZATION. THE REPORTER INDICATED THAT THE SHAFT OF THE SCOPE HAS A SLIGHT BEND IN IT. THE SURGEON THEN CONVERTED FROM AN ARTHROSCOPIC PROCEDURE TO AN OPEN PROCEDURE. THE PROCEDURE WAS A RIGHT HAND CARPAL TUNNEL RELEASE. THE PATIENT WAS REPORTED TO HAVE BEEN RELEASED AS SCHEDULED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334687 SCOPE, REVERSE LIGHTPOST, 2.9MM, 30 DEG ARTHROSCOPE HRX ARTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other