BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION ULTRAVIT PROBE

    MDR report key: 11655805 · Received April 13, 2021

    Report

    Report Number
    1644019-2021-00248
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 7, 2021
    Report Date
    October 25, 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

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; HOWEVER, THE PRODUCT PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION IS AVAILABLE, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. 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 · 0

    ONE OPENED PROBE WAS RECEIVED WITH A TIP PROTECTOR, IN A BAG. THE RETURNED 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 WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. EXCESSIVE 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 MULTIPLE 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 ROOT CAUSE FOR THE ACTUATION AND CUT FAILURES, AS WELL AS THE OBSERVED FOREIGN MATERIAL, IS THE EXCESSIVE SURGICAL USE OF THE PROBE. THE VITRECTOMY PORTION OF THE PROCEDURE IS TYPICALLY LESS THAN 20 MINUTES AND IT APPEARS THAT THE PROBE HAS EXPERIENCED A USE MUCH GREATER THAN THIS TYPICAL TIMEFRAME. THE EXCESS USAGE OF THE PROBE WILL WEAR AND DAMAGE THE INNER CUTTER SUCH THAT THE CUTTER FUNCTION BECOMES POOR, BENT, OR DOES NOT FUNCTION AT ALL. NO ACTION HAS BEEN TAKEN AS IT APPEARS THAT THE OBSERVED ACTUATION AND CUT FAILURES WERE DUE TO EXCESSIVE USE OF THE PROBE BY THE USER. PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. ANY NON-CONFORMANCES FOUND ARE REMOVED FROM THE LOT AND SCRAPPED. 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 DID NOT CUT DURING SURGERY. ASPIRATION WAS WORKING. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555410 CONSTELLATION ULTRAVIT PROBE VITRECTOMY, INSTRUMENT CUTTER MLZ NA ASKU 00380657509492

    Patients

    Seq Age Sex Outcome Treatment
    1