BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP FIRSTPASS STR PASSR SELF

    MDR report key: 9189226 · Received October 14, 2019

    Report

    Report Number
    3006524618-2019-00507
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 30, 2019
    Report Date
    March 2, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER 2023580 SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW FOR LOT NUMBER 2023580 FOR THE PAST 3 YEARS FOUND NO RELATED FAILURES. VISUAL INSPECTION SHOWS A DEVICE WHICH WAS RETURNED DEPLOYED. THE INSTRUMENT WAS RETURNED WITH AN OPENED BRACKET. THERE WERE NO MANUFACTURING ABNORMALITIES FOUND ON THE DEVICE. FUNCTIONAL EVALUATION REVEALED THAT THE TWO STEP TRIGGER PERFORMED AS INTENDED. THE BRACKET COULD BE OPENED /CLOSED AS SPECIFIED. THE NEEDLE COULD BE EXTENDED WITHOUT ANY ISSUES. THE COMPLAINT WAS NOT VERIFIED AS THE DEVICE PERFORMED AS INTENDED DURING THE TEST. THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY AS THE DEVICE PERFORMED AS INTENDED. FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDES: (1) IMPROPER HANDLING OF THE TWO STEP TRIGGER (2) THE BRACKET GET CAUGHT ON TISSUE (3) THE BRACKET GOT STICKY DURING THE SURGERY THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON WAS ABLE TO FIRE THE NEEDLE USING THE TRIGGERS, BUT THE NEEDLE DID NOT RETURN TO THE INITIAL POSITION. NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983216 DISP FIRSTPASS STR PASSR SELF PASSER HWQ ARTHROCARE CORP. 22-4038 2023580

    Patients

    Seq Age Sex Outcome Treatment
    1