BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER PROBES

    MDR report key: 7283912 · Received February 20, 2018

    Report

    Report Number
    2028159-2018-00337
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    January 22, 2018
    Report Date
    June 21, 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
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. HOWEVER, A PROBE WAS RETURNED FOR EVALUATION. THE PROBE WAS PACKAGED ON JUNE 28, 2017. THERE WERE 1,116 PAKS ASSOCIATED WITH THIS LOT. THE 25GA PROBE WERE MANUFACTURED ON JUNE 21, 2017. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE 25G PROBE WAS RECEIVED FOR EVALUATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED ADHESIVE ON THE CANNULA TIP. THE 25GA PROBE WAS INSERTED INTO A 25G TROCAR. THE SAMPLE GOT STUCK WHEN INSERTED INTO THE 25G TROCAR, CONFIRMING THE REPORTED EVENT. ADDITIONALLY, THE SAMPLE¿S CANNULA OUTER DIAMETER (OD) WAS MEASURED AT ITC RECEIVING INSPECTION PER DRAWING 460-1254-004, REV. P0. WITH AN OD MIN/MAX VALUES OF 0.0200 TO 0.0205 INCHES, THE SAMPLE¿S CANNULA OD WAS MEASURED TO BE 0.02001 TO 0.02030, MEETING SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO EXCESS ADHESIVE RESIDUE ON THE LASER PROBE TIP DURING MANUFACTURING. AN INTERNAL INVESTIGATION WAS OPENED FOR THIS ISSUE. 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 DURING A VITRECTOMY PROCEDURE, THE TIP OF THE PROBE COULD NOT BE INSERTED INTO THE CANNULA. THE LASER PROBE WAS EXCHANGED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125769 LASER PROBES INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED HQE ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA 17024845X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other