BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION DSP 25G FORCEPS

    MDR report key: 1645546 · Received March 12, 2010

    Report

    Report Number
    3003398873-2010-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Report Date
    February 5, 2010
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED; THIS IS THE FIRST EVENT REPORTED REGARDING THIS ISSUE FOR THIS FACILITY. THE DEVICE HISTORY RECORDS WERE REVIEWED. THE LOTS WERE RELEASED BASED ON ALCON'S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS VISUALLY AND FUNCTIONALLY INSPECTED. NO DAMAGE COULD BE FOUND. THE SAMPLE WAS TESTED ACCORDING TO THE FINAL INSPECTION INSTRUCTION AND IT MET ALL SPECS (APART FROM THE SURGICAL RESIDUES). ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION AS THE SAMPLE MET ACCEPTANCE CRITERIA. QUALITY ASSURANCE WILL MONITOR RELATED COMPLAINTS AND WILL TAKE ACTION FOR FURTHER OCCURRENCES AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    MALFUNCTION: IN OPERATIONAL DEVICE. THE SURGEON REPORTED THAT THE FORCEPS WOULD NOT GRASP THE TISSUE. THE FORCEPS WERE REPLACED AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY. THE SURGEON REPORTED THE PT WAS NO IMPACTED BY THIS EVENT. ADDITIONAL FOLLOW-UP INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION DSP 25G FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG 705.43 F74814

    Patients

    Seq Age Sex Outcome Treatment
    1