BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION PNEUMATIC HANDPIECE

    MDR report key: 11727571 · Received April 26, 2021

    Report

    Report Number
    3003398873-2021-00028
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    February 16, 2021
    Report Date
    June 29, 2021
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HQC
    UDI-DI
    07612717071391
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS D.9, H.3, H.6 AND H.10. THE SAMPLE WAS RECEIVED IN OPENED ORIGINAL PACKAGING INCLUDING THE COVER FOIL. 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. THE SAMPLE WAS VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS. THE SHUTTER WAS FOUND TO HAVE SCRATCHES INDICATING THE USE OF TOOLS. BASED ON THESE MARKS, IT CAN BE ASSUMED THAT THE INSTRUMENT WAS DAMAGED DURING USE. IT IS POSSIBLE THAT THE SHUTTER WAS FIRST TURNED IN THE WRONG DIRECTION AND THEREFORE JAMMED. THE CORRECT HANDLING OF THE DEVICE IS DESCRIBED IN THE DIRECTION FOR USE (DFU) OF THE INSTRUMENT. THIS EVENT IS ATTRIBUTED TO USER HANDLING. THE DEVICE WAS DAMAGED DURING HANDLING. THE CORRECT HANDLING OF THE INSTRUMENT IS DESCRIBED IN THE INSTRUMENTS DFU. 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

    A SAMPLE IS AVAILABLE THAT HAS NOT YET BEEN RECEIVED AT 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 PHYSICIAN REPORTED THAT THE CONNECTION PART OF AN OPHTHALMIC PNEUMATIC HANDPIECE WOULD NOT ALLOW FOR A FORCEPS TIP TO SCREW IN AND CONNECT PRIOR TO PERFORMING THE SCHEDULED COMBINATION CATARACT AND VITRECTOMY SURGERY. THERE WAS NO HARM TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622234 CONSTELLATION PNEUMATIC HANDPIECE UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE HQC ALCON GRIESHABER AG NA F183254 07612717071391

    Patients

    Seq Age Sex Outcome Treatment
    1