BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER REVOLUTION DSP FORCEPS

    MDR report key: 7086198 · Received December 6, 2017

    Report

    Report Number
    3003398873-2017-00031
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 11, 2017
    Report Date
    April 25, 2018
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS PROVIDED. A FORCEPS SAMPLE WITH PROTECTIVE BUBBLE WRAP WAS RECEIVED WITH THE ORIGINAL INNER BLISTER. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND AND THE PRODUCT WAS RELEASED ACCORDING TO ACCEPTANCE CRITERIA. A 100% FINAL INSPECTION IS PERFORMED FOR THIS PRODUCT. THE SAMPLE WAS VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS. THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. IT WAS FOUND THAT THE TUBE IS LOOSE. THE COMPLAINT HISTORY WAS REVIEWED TWO YEARS BACK. IT SHOWED COMPARABLE COMPLAINTS AS TO THE DAMAGE. IT CANNOT BE EXCLUDED THAT THE METAL TUBE LOOSENED AND THEREFORE A PROPER ACTIVATION WAS NO LONGER POSSIBLE. THIS KIND OF DAMAGE WAS ALREADY DETECTED AND INVESTIGATED. IT RESULTED THAT THE METAL TUBES MAY LOOSEN DUE TO AN IMPROPERLY PERFORMED BONDING PROCEDURE. BASED ON THE AVAILABLE DATA, THIS IS A SINGLE EVENT FOR THIS FINISHED PRODUCT LOT AND SUB-ASSEMBLY LOT. A DESIGN RELATED ROOT CAUSE FOR THE DAMAGE OF THE COMPLAINED DEVICE HAS NOT BEEN IDENTIFIED. NO FURTHER ACTIONS ARE NECESSARY. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT CANNOT BE ANTICIPATED FOR THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN OPHTHALMIC FORCEPS COULD NOT BE LOOSENED AFTER IT WAS PRESSED DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY USING THE COMPLAINT DEVICE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868014 GRIESHABER REVOLUTION DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA F126947

    Patients

    Seq Age Sex Outcome Treatment
    1 Other