BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED MEMBRANE SCRAPER

    MDR report key: 7108622 · Received December 12, 2017

    Report

    Report Number
    3003398873-2017-00032
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 14, 2017
    Report Date
    February 6, 2018
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HND
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RECEIVED FOR EVALUATION. 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. A PICTURE OF THE FOUND AND REMOVED METAL PIECE HAS BEEN PRESENTED TO THE MANUFACTURER. ACCORDING TO THE DETAILS VISIBLE ON THE PICTURE, THE FOLLOWING STATEMENT CAN BE GIVEN: THE METAL PIECE ON THE PICTURE LOOKS LIKE THE FLEX LOOP OF THE PRODUCT AS USED DURING THE SURGICAL PROCEDURE. THIS FLEX LOOP IS BONDED INTO THE INSTRUMENT. DUE TO ITS GEOMETRY, THE LOOP IS SLIGHTLY BENT ON THE DISTAL END. THE LOOP ON THE PICTURE OF THE COMPLAINT INSTRUMENT SHOWS AN ADDITIONAL BENDING IN THE MIDDLE OF ITS LENGTH WHICH DOES NOT HAVE ITS ORIGIN IN PRODUCTION. WHERE THIS BENDING IN THE MATERIAL COMES FROM CANNOT BE ANALYZED ANYMORE. IMPORTANT FOR THE SPECIFIC INSTRUMENT IS THAT IT IS INSERTED INTO THE EYE THROUGH THE TROCAR IN RETRACTED POSITION AS DESCRIBED IN THE USER MANUAL. OTHERWISE, THE LOOP WILL BE DAMAGED WHEN PUSHED THROUGH THE TROCAR. IT CAN BE ASSUMED THAT THE ADDITIONAL BENDING ON THE LOOP COMES FROM THE TECHNIQUE DURING THE INSERTION OF THE INSTRUMENT. IF THIS WOULD BE THE CASE, THE BONDING BETWEEN THE LOOP AND THE INSTRUMENT COULD HAVE BEEN DAMAGED DURING INSERTION IN A NON-RETRACTED SITUATION. AFTER USING THE INSTRUMENT, THE LOOP MIGHT HAVE BEEN RETRACTED INTO THE INSTRUMENT TO TAKE THE INSTRUMENT OUT OF THE EYE. DURING THIS PROCEDURE THE LOOP MIGHT HAVE BEEN LOST IN THE EYE. THIS IS THE ONLY POSSIBLE STATEMENT WHY THE LOOP HAS BEEN LOST IN THE EYE. SINCE THIS IS A SINGLE CASE, NO COMPARISON CAN BE MADE TO GET A MORE DETAILED UNDERSTANDING OF THIS COMPLAINT. A DETAILED INVESTIGATION COULD NOT BE INITIATED. NO SAMPLE ARRIVED FOR INVESTIGATION. NO FURTHER ACTIONS WILL BE ISSUED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY 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. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT DURING A SECONDARY PROCEDURE, THE CHIPPED PART OF THE DEVICE WAS REMOVED FROM THE PATIENT'S EYE. CORTICOSTEROIDS, PROUROKINASE AND NSAIDS WERE ADMINISTERED. THE PATIENT'S ISSUE IS AGAIN REPORTED AS RESOLVED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT AN OPHTHALMIC MEMBRANE SCRAPPER WAS USED DURING A PROCEDURE IN WHICH A CHIPPED PART OF THE DEVICE WAS DETECTED IN THE POSTERIOR SEGMENT OF THE PATIENT'S EYE DURING A TWO WEEK POSTOP EXAMINATION. THE CHIPPED PART WAS SURGICALLY REMOVED FROM THE PATIENT'S EYE. THE PATIENT'S STATUS WAS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889615 CURVED MEMBRANE SCRAPER SPATULA, OPHTHALMIC HND ALCON GRIESHABER AG NA F145791

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other