BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER PROBES

    MDR report key: 6513291 · Received April 21, 2017

    Report

    Report Number
    2028159-2017-01730
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Report Date
    July 13, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K946135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. HOWEVER, THE PROBE WAS RETURNED FOR EVALUATION. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE PROBE WAS MANUFACTURED ON OCTOBER 3, 2016. THERE WERE 930 PAKS ASSOCIATED WITH THIS LOT. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY RELATED NON-CONFORMITY DURING MANUFACTURING FOR THIS PRODUCT. THE ASSOCIATED SYSTEM WAS MANUFACTURED ON JUNE 6, 2011. BASED ON QA ASSESSMENT, BOTH PRODUCTS MET SPECIFICATIONS AT THE TIME OF RELEASE. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED A BUMP ON THE CANNULA TIP NEAR THE JUNCTION OF THE NITINOL FLEXIBLE TIP. REFER TO THE ATTACHED INVESTIGATION PHOTO. THE LASER PROBE WAS INSERTED INTO A 25GA TROCAR, BUT THE TIP BECAME STUCK. THE SAMPLE WAS EVALUATED AT RECEIVING INSPECTION (RI) ON JUNE 16, 2016, WHERE THE LASER PROBE CANNULA TIP OUTER DIAMETER WAS MEASURED. IT WAS NOTED THAT THE CANNULA TIP WAS DAMAGED AND FLAT ON ONE SIDE. ONE SIDE OF CANNULA TIP OUTER DIAMETER WAS FOUND TO BE 0.01735IN TO 0.02280IN, WHILE THE OTHER SIDE WAS 0.01615IN TO 0.2280IN. BOTH SIDE WERE OUT OF THE UPPER SPECIFICATION LIMIT OF 0.0205IN PER DRAWING 460-1254-004 REV P0. THE SAMPLE DID NOT MEET SPECIFICATIONS. ROOT CAUSE THE SAMPLE WAS FOUND TO HAVE A BUMP ON THE CANNULA NEAR THE JUNCTION OF THE NITINOL FLEXIBLE TIP. HOWEVER, HOW OR WHEN THE SAMPLE BECAME NONCONFORMING COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT DURING A PROCEDURE THE "ROOT" PART OF THE LASER PROBE WOULD NOT FIT INTO THE TROCAR CANNULA. THE SURGERY WAS COMPLETED USING AN ALTERNATE LASER PROBE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291978 LASER PROBES INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED HQE ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA 16038825X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSTELLATION,TABLETOP,(B)(6)