BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE SMARTRELEASE HANDPIECE

    MDR report key: 8642068 · Received May 24, 2019

    Report

    Report Number
    2020601-2019-00004
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 23, 2019
    Report Date
    March 4, 2020
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A REVIEW OF COMPLAINT FILES, IT WAS IDENTIFIED THAT A SUPPLEMENTAL SUBMISSION WAS NOT SUBMITTED FOR MDR# 2020601-2019-00004 TO TIE IT TO RECALL# 2020601-06-04-19-001-R WHICH WAS INITIATED AND SUBMITTED IN JUNE 2019. THE RECALL HAS SINCE BEEN COMPLETED. THIS SUPPLEMENTAL SUBMISSION IS BEING SUBMITTED TO LINK THE MDR WITH ITS CORRESPONDING RECALL.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION HAS CONFIRMED THE REPORTED ISSUE OF THE BLADE NOT RETRACTING FOLLOWING RELEASE OF THE HANDPIECE'S TRIGGER. IN RESPONSE TO THIS, MICROAIRE SURGICAL INSTRUMENTS HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE CAUSE OF THE CONFIRMED ISSUE WITH PART# 81014, SMARTRELEASE HANDPIECE AND DETERMINE ANY NECESSARY ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, FOLLOWING A CARPAL TUNNEL SURGERY USING SMART RELEASE HANDPIECE (PART# 81014 / EITHER SERIAL# (B)(4)) WITH STANDARD BLADE ASSEMBLY (PART# 81010-6 / LOT# 0119335385), THE BLADE DID NOT RETRACT UPON RELEASING THE HANDPIECE'S TRIGGER. FOLLOWING THE PROCEDURE, THE UNIT WAS TAKEN TO THE SURGERY CENTER'S DECONTAMINATION ROOM FOR DISASSEMBLY AND CLEANING/STERILIZATION. WHILE REMOVING THE STANDARD BLADE ASSEMBLY FROM THE SMART RELEASE HANDPIECE, THE STERILE PROCESSING TECHNICIAN DID NOT REALIZE THAT THE BLADE ON THE STANDARD BLADE ASSEMBLY HAD NOT RETRACTED AND WAS CUT ON THE HAND. THE CUT WAS DESCRIBED AS A PUNCTURE WOUND WHICH DID NOT REQUIRE ANY MEDICAL INTERVENTION, ASIDE FROM THE TECHNICIAN BEING SENT FOR INFECTIOUS DISEASE TESTING. THE TECHNICIAN RECOVERED FULLY WITH NO KNOWN COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436143 MICROAIRE SMARTRELEASE HANDPIECE CARPAL TUNNEL RELEASE HANDPIECE NBH MICROAIRE SURGICAL INSTRUMENTS 81014 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other