BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER REVOLUTION DSP FORCEPS

    MDR report key: 6033655 · Received October 17, 2016

    Report

    Report Number
    3003398873-2016-00017
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 30, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BY MANUFACTURING THAT HAS NOT YET BEEN EVALUATED. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND IN THE PRODUCTION DOCUMENTATION AND THE SAMPLE WAS RELEASED ACCORDING TO THE MANUFACTURER'S ACCEPTANCE CRITERIA. A 100% FINAL INSPECTION IS PERFORMED FOR THIS PRODUCT. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED A FORCEPS SAMPLE FOR EVALUATION. THE SAMPLE WAS RECEIVED WITH THE ORIGINAL OUTER AND INNER BLISTER INCLUDING THE COVER FOIL AND WAS PROTECTED WITH BUBBLE WRAP. THE SAMPLE WAS VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS. THE CUSTOMER¿S COMPLAINT WAS CONFIRMED AS THE FORCEPS IS UNABLE TO OPEN OR CLOSE. THE COMPLAINT HISTORY WAS REVIEWED FOR THE TWO PREVIOUS YEARS WHICH SHOWED SEVEN COMPARABLE COMPLAINTS. DURING ACTIVATION OF THE INSTRUMENT, IT WAS NOTED THAT THE TUBE HAS BEEN LOOSENED AND PROPER ACTIVATION WAS NO LONGER POSSIBLE. BASED ON THE RESULTS OF THE PRODUCT EVALUATION, A MALFUNCTION OF THE DEVICE OCCURRED DUE TO AN IMPROPERLY PERFORMED BONDING PROCEDURE. THE ROOT CAUSE ANALYSIS OF THIS COMPLAINT HAS BEEN COMPLETED. DUE TO THE COMPLAINT HISTORY IT CANNOT BE EXCLUDED THAT THE BONDING SURFACE OF THE METAL TUBE AND PLASTIC FRONT LOOSENED DUE TO AN IMPROPERLY PERFORMED BONDING PROCEDURE. BONDING IS A MANUAL PROCESS DESCRIBED IN A WORK INSTRUCTION AND CONTROLLED BY THE EMPLOYEE. THE INVESTIGATION SHOWED THAT APPLICATION OF THE ADHESIVE HAS BEEN DONE IN ONE STEP INSTEAD OF TWO STEPS AS DESCRIBED IN THE WORK INSTRUCTION. THIS LED TO UNCONTROLLED DISTRIBUTION OF THE ADHESIVE IN THE SUBASSEMBLY. THIS RESULTED IN A SUB OPTIMAL BONDING STRENGTH BETWEEN THE METAL TUBING AND THE PLASTIC FRONT TIP. CORRECTIVE ACTIONS WERE DEFINED. ALL INVOLVED EMPLOYEES WERE RETRAINED AND THE CIRCLE OF APPROVED TRAINERS WAS RESTRICTED TO EXPERTS. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC FORCEPS UNIT WOULD NOT REOPEN AFTER IT WAS CLOSED DURING SURGERY. THIS WAS NOTED PRIOR TO ANY PATIENT CONTACT THUS, THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686894 GRIESHABER REVOLUTION DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA F132048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other