BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER REVOLUTION DSP FORCEPS

    MDR report key: 11605468 · Received April 1, 2021

    Report

    Report Number
    3003398873-2021-00024
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 11, 2021
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    UDI-DI
    07612717070622
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TWO SAMPLES WERE RECEIVED IN INNER AND OUTER BLISTERS. ONE COVER FOIL WAS INCLUDED. 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 TWO RECEIVED FORCEPS SAMPLES WERE VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS. AFTER CLEANING, IT WAS FOUND THAT THE TUBES ARE LOOSE WHICH BLOCK THE FORCEPS FROM ACTIVATING. THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. ROOT CAUSE COULD BE DETERMINED TO BE AN IMPROPERLY PERFORMED BONDING PROCEDURE. INVESTIGATIONS PERFORMED IN 2018 BY THE ASSOCIATED MANUFACTURING SITE LED TO AN IMPROVEMENT IN THE BONDING PROCESS WHEREBY AN ADDITIONAL 4TH GLUING DOT WAS APPLIED INSTEAD OF THREE, ENSURING A BETTER CONNECTION BETWEEN THE TIP-TUBE AND SLEEVE. THE FORCEPS DEVICES MANUFACTURER AT THE LOCATION OF THE COMPLAINT SAMPLE HAD NOT YET BEEN INFORMED ABOUT THE PROCESS OF INCLUDING A 4TH DROP OF OPERATOR APPLIED GLUE. THE PROCESS OF HAVING THE OPERATOR APPLY AN ADDITIONAL, 4TH DROP OF GLUE TO THE DEVICE DURING MANUFACTURING INSTEAD OF THREE DROPS WAS REPORTED TO MANUFACTURER IN THE MEANWHILE AND THE PROCESS HAS SINCE BEEN IMPLEMENTED. DATA WILL CONTINUE TO BE MONITORED FOR EVIDENCE OF TRENDING. 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 TWO OPHTHALMIC FORCEPS FAILED TO OPEN WHEN THEY WERE INSERTED INTO THE PATIENT'S EYE DURING A VITRECTOMY SURGERY. AN ALTERNATE FORCEPS WAS OBTAINED IN ORDER TO COMPLETE THE SURGERY. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503246 GRIESHABER REVOLUTION DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA 320682M 07612717070622

    Patients

    Seq Age Sex Outcome Treatment
    1