BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION ULTRAVIT PROBE

    MDR report key: 11655659 · Received April 13, 2021

    Report

    Report Number
    1644019-2021-00247
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 7, 2021
    Report Date
    October 31, 2021
    Product Code
    MLZ
    UDI-DI
    00380657509492
    PMA / PMN Number
    K093305
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED PROBE WAS RECEIVED WITH A TIP PROTECTOR, IN A TRAY. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NON-CONFORMING WITH ORANGE/BROWN FOREIGN MATERIAL ON THE PORT FACE. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION AND CUT AND WAS FOUND TO BE NON-CONFORMING FOR BOTH FUNCTIONAL TESTS. THE PROBE SAMPLE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. NO/MINIMAL WEAR WAS OBSERVED ON THE INNER CUTTER WHEN COMPARED TO THE DEGREE OF WEAR BASED ON CONTINUOUS ACTUATION OF THE PROBE VISUAL STANDARD PHOTOS. GOUGE MARKS WERE OBSERVED AT THE CUTTING EDGE AND A COUPLE OTHER LOCATIONS ALONG THE INNER CUTTER. THE SAMPLE WAS RETESTED FOR ACTUATION WITH THE PROBE DRIVER AND WAS ABLE TO ACTUATE. THE INITIAL ACTUATION TEST FAILED DUE TO AN INTERFERENCE WITHIN THE PROBE AND ONCE THE INTERFERENCE (NEEDLE ASSEMBLY) WAS REMOVED THE PROBE WAS ABLE TO ACTUATE. THE NEEDLE HOLDER / RETAINER ASSEMBLY WAS THEN DISASSEMBLED AND COMPONENTS INSPECTED. THE COMPONENTS WERE FOUND TO BE CONFORMING. THE COMPLAINT EVALUATION CONFIRMS THAT THE PROBE SAMPLE HAD A CUT FAILURE AND ALSO INDICATED THAT THE SAMPLE HAD AN ACTUATION FAILURE. THE MOST LIKELY CAUSE FOR THE CUT FAILURE IS THE OBSERVED GOUGE MARKS ON THE CUTTING EDGE OF THE INNER CUTTER OF THE PROBE. A DAMAGED CUTTING EDGE CAN DECREASE THE QUALITY OF THE CUT PERFORMED BY THE PROBE. HOW AND WHEN THE CUTTING EDGE OF THE INNER CUTTER OF THE PROBE BECAME DAMAGED CANNOT BE DETERMINED FORM THIS EVALUATION. THE EXACT CAUSE OF THE ACTUATION FAILURE CANNOT BE DETERMINED FROM THE EVALUATION PERFORMED. THE EXACT ROOT CAUSE OF THE CUT AND ACTUATION FAILURES COULD NOT BE DETERMINED, THEREFORE, NO SPECIFIC ACTION WITH REGARD TO THIS COMPLAINT WAS TAKEN BY THE MANUFACTURING SITE. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. COMPLAINTS WILL BE CONTINUED TO BE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO FURTHER ACTIONS ARE REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED FOR EVALUATION. THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE. AND THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA. THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN. THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PROBE COULD NOT CUT AND THE ASPIRATION WAS WORKING DURING SURGERY. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556462 CONSTELLATION ULTRAVIT PROBE VITRECTOMY, INSTRUMENT CUTTER MLZ NA 2395700H 00380657509492

    Patients

    Seq Age Sex Outcome Treatment
    1