BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER ULTRASHARP KNIFE

    MDR report key: 12053298 · Received June 23, 2021

    Report

    Report Number
    3003398873-2021-00041
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 25, 2021
    Report Date
    August 12, 2021
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNN
    UDI-DI
    07612717000063
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. SAMPLE RECEIVED IN OPENED ORIGINAL PACKAGING WITHOUT COVER FOIL. THE SAMPLE WAS VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS. SOME RESIDUALS ARE VISIBLE. AFTER CLEANING DEVICE WAS REVIEWED WITH A TECHNICAL EXPERT FROM MANUFACTURING. IT WAS FOUND THAT THE BLADE MEETS THE SPECIFICATIONS. NO DAMAGE VISIBLE ON THE BLADE. DEVICE WAS 100% TESTED DURING MANUFACTURING PROCESS. THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. NO CORRECTIVE ACTIONS ARE REQUIRED, BECAUSE THERE IS NO INDICATION OF A MALFUNCTION. THIS COMPLAINT HAS BEEN REVIEWED AND FUTURE DATA WILL BE MONITORED FOR EVIDENCE OF ADVERSE TRENDING AND FURTHER ACTION WILL BE TAKEN, AS APPROPRIATE. AT A MINIMUM, THIS WILL INCLUDE COMPLETING REVIEWS OF COMPLAINT CLASS REPORT LEVELS ON A MONTHLY BASIS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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 NURSE REPORTED THAT DURING A CATARACT EXTRACTION SURGERY, AN OPHTHALMIC KNIFE BLADE WAS FOUND TO BE DULL WHEN THE SURGEON ATTEMPTED TO MAKE THE PARACENTESIS. THERE WAS NO REPORT OF ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED FURTHER CLARIFIED THAT AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945682 GRIESHABER ULTRASHARP KNIFE KNIFE, OPHTHALMIC HNN ALCON GRIESHABER AG NA F175500 07612717000063

    Patients

    Seq Age Sex Outcome Treatment
    1