BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3909922 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00100
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Report Date
    February 16, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT NOT RETURNED DUE TO PT CONTACT. ON (B)(4) 2014: QA ASKED CUSTOMER SERVICE TO CALL THE SALES REP AND DETERMINED THE DATE OF INCIDENCE SINCE THIS LOT WAS MADE MARCH 2012 AND THE EXPIRATION DATE IS MAY-12; CUSTOMER SERVICE CALLED AND WAS UNABLE TO GET AN ANSWER. ON (B)(4) 2012: QA REQUESTED A SECOND ATTEMPT, CUSTOMER SERVICE SENT AN EMAIL REQUESTING THE INFO FROM (B)(4) HEALTHCARE. ON (B)(4) 2014: (B)(4) REFERRED CUSTOMER SERVICE TO (B)(4); EMAIL WAS SENT; NO RESPONSE ON RECORD COMPLAINT CLOSED; AS OF THIS DATE, THERE ARE(B)(4). ON 02/04/2014: OPENED CAPA (B)(4) TO REVIEW 2012 COMPLAINTS. UPDATED WITH THE FOLLOWING DETAILS: THE UNIT HAD MADE PT CONTACT AND WAS NOT RECEIVED FOR EVAL. IT IS NOT POSSIBLE TO DETERMINE AN ASSIGNABLE CAUSE FOR THIS ISSUE. THERE IS INSUFFICIENT INFO FOR A COMPLETE INVESTIGATION. THIS LOT HAD A 3-MONTH EXPIRATION DATE. IF THE UNIT WAS USED PASSED THE EXPIRATION, WITH THE SEAL INTACT, IT WOULD STILL REMAIN STERILE. REFER TO ACCELERATED AGING REPORT #(B)(4). THE DHR FOR LOT 06512-08 WAS REVIEWED. THE UNIT MET MFG SPECS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THIS LOT HAD A (B)(4)COMPLAINT RATE. THERE WERE (B)(4) UNITS RELEASED TO DISTRIBUTION. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE A TOTAL OF (B)(4) UNITS THAT STOPPED WORKING. PRIMING ISSUE POSSIBLY DUE TO A SPACER OR VALVE ISSUE, REFER TO CAPA (B)(4). A REVIEW OF THE CONSOLE HISTORY WAS NOT PERFORMED BECAUSE THE CONSOLE SERIAL NUMBER WAS NOT REPORTED WITH THE COMPLAINT.

    Description of Event or Problem · 1

    WOULD NOT "PRIMEAND" CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114436 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 06512-08

    Patients

    Seq Age Sex Outcome Treatment
    1