BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER PROBES

    MDR report key: 7440373 · Received April 18, 2018

    Report

    Report Number
    2028159-2018-00789
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 20, 2018
    Report Date
    July 9, 2018
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TWO 25 G PROBES WERE RECEIVED FOR EVALUATION. PROBE TWO WERE MANUFACTURED ON DECEMBER 20, 2017. THERE WERE 1284 PAKS ASSOCIATED WITH THIS LOT. THE LASER PROBES WERE MANUFACTURED ON DECEMBER 4 AND DECEMBER 5 OF 2017, RESPECTIVELY. THERE WERE 95 PROBES ASSOCIATED WITH EACH LOT. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. A VISUAL ASSESSMENT OF THE RETURNED SAMPLES SHOWED NO OBVIOUS NONCONFORMITIES. THE LASER PROBES WERE INSERTED INTO A 25GA TROCAR CANNULA AND PASSED THROUGH WITH NO NOTICEABLE RESISTANCE. THE SAMPLES¿ OUTER CANNULA DIAMETERS WERE MEASURED PER DRAWING 460-1254-004, REV. P0. WITH AN OUTER DIAMETER MIN/MAX VALUES OF 0.0200 TO 0.0205 INCHES, THE TWO SAMPLES¿ OUTER DIAMETER WERE MEASURED TO BE 0.0202-0.0203 AND 0.02015-0.0203 INCHES, BOTH MEETING SPECIFICATIONS. THE SAMPLES WERE FOUND TO MEET SPECIFICATIONS; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. 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).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE LASER PROBES WERE GETTING STUCK IN THE TROCARS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE LASER PROBE WAS GETTING STUCK IN THE TROCARS. ADDITIONAL INFORMATION REPORTS THAT THE PRODUCT WAS EXCHANGED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282038 LASER PROBES INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED HQE ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA 17038654X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other