BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3190688 · Received June 21, 2013

    Report

    Report Number
    2028159-2013-01228
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE 23 GAUGE VITRECTOMY PROBE. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING FOR BENT NEEDLE AND A CRACKED BOND ON THE BODY NEEDLE INTERFACE. THE SAMPLE WAS FUNCTIONALLY TESTED AND FOUND TO BE CONFORMING FOR ASPIRATION AND ACTUATION, BUT NONCONFORMING FOR CUT. THE PROBE WAS DISASSEMBLED AND COMPONENTS EVALUATED. THERE WAS SIGNIFICANT RESISTANCE FELT WHILE REMOVING THE INNER CUTTER FROM THE BENT NEEDLE. THERE WERE WEAR MARKS ON THE AREA OF THE BEND ON THE INNER CUTTER SHAFT AND THE CUTTING EDGE EXHIBITS SIGNIFICANT NICKS AND GOUGES. THE PROBE APPEARS TO BE SIGNIFICANTLY WORN OUT. THREE LOT NUMBERS WERE IDENTIFIED WITH THE COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. THE ASPIRATION TESTING DID NOT CONFIRM THE COMPLAINT REPORT FOR ASPIRATION DYSFUNCTION; THE PROBE WAS FOUND TO BE CONFORMING TO ASPIRATION FUNCTIONAL REQUIREMENTS. THE BENT NEEDLE AND SIGNIFICANTLY WORN OUT CUTTING EDGE AFFECTED THE CUTTING ABILITY OF THE PROBE. THE BENT NEEDLE WITH A CRACKED BOND IS AN INDICATION THAT THE PROBE HAD SIGNIFICANTLY BENT. UNABLE TO DETERMINE HOW OR WHEN THE NEEDLE BECAME BENT. A BEND THIS OBVIOUS WOULD HAVE BEEN DETECTED DURING ASSEMBLY AND TESTING. THE DAMAGED CUTTING EDGE WAS THE MAIN REASON FOR THE CUTTING FAILURE DUE TO SIGNIFICANT USE OF THE PROBE. ALL PROBE COMPONENTS ARE 100% INSPECTED BY TRAINED OPERATORS DURING MFG. ANY NONCONFORMANCE DETECTED (SUCH AS "BENT NEEDLE", AND "WOULD NOT CUT") WOULD HAVE BEEN REMOVED FROM THE LOT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH THE CASSETTE AND VITRECTOMY PROBE DURING SURGERY, WITH LACK OF ASPIRATION AND MORE OR LESS A SMALL REFLUX ASSOCIATED WITH CUTTING. THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283080 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON MANUFACTURING, LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY PAK 23 5.0 CPM