BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE 23GA VITRECTOMY CUTTER

    MDR report key: 19704176 · Received July 9, 2024

    Report

    Report Number
    3012236936-2024-000185
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 12, 2024
    Report Date
    October 18, 2024
    Manufacturer
    KIRWAN
    Product Code
    MLZ
    UDI-DI
    05050474534100
    PMA / PMN Number
    K081681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: JULY 25TH, 2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: INITIAL OBSERVATIONS BEFORE ATTEMPTING TO DUPLICATE THE FAILURE: PETROLATUM-LIKE MATERIAL WAS FOUND ON THE CUTTER NEAR THE PORT. FAILURE WAS DUPLICATED. FUNCTIONAL TESTS WERE PERFORMED FOR ASPIRATION, RETRACTION, CLOSURE AND SINGLE CUT, PROBE SUCCESSFULLY PASSED ALL TESTS. THE ORIGINAL REASON FOR INVESTIGATION WAS ADDRESSED, FAILURE WAS SUCCESSFULLY DUPLICATED AS PETROLEUM-LIKE MATERIAL WAS FOUND NEAR THE PORT OF THE CUTTER. ROOT CAUSE ANALYSIS: A REVIEW OF THE CUSTOMER-PROVIDED VIDEO FOOTAGE AND FAILURE ANALYSIS OF THE RETURNED DEVICE CONCLUDED THAT THE FOREIGN SUBSTANCE THAT LEAKED OUT OF THE PROBE WAS LIKELY PETROLATUM, A LUBRICANT, AND A PROCESSING AGENT USED DURING THE PROBE ASSEMBLY IN MANUFACTURING. MID LABS HAS FULLY ASSESSED AND IDENTIFIED THE HEALTH HAZARDS OF ALL MANUFACTURING/PROCESSING AGENTS, INCLUDING THE PETROLATUM, AND DETERMINED THAT THE OVERALL TOXICITY EFFECT OF THE VITREOUS CUTTER IS NEGLIGIBLE AND CONSIDERED BIOCOMPATIBLE FOR USE AS INTENDED. FURTHER INVESTIGATION HAS BEEN INITIATED TO IDENTIFY THE ROOT CAUSE IN THE MANUFACTURING PROCESS AND BASED ON THE OUTCOME OF THIS FURTHER INVESTIGATION, ACTION PLANS WILL BE DEVELOPED. CONCLUSION: ALTHOUGH A DEFINITIVE ROOT CAUSE HAS NOT BEEN CONFIRMED AT THIS TIME, JOHNSON & JOHNSON SURGICAL VISION, INC. WILL CONTINUE TO MONITOR THESE TYPES OF EVENTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION E1 - TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE WHILE USING THE DEVICE, A FOREIGN MATERIAL LIKE A WHITE SOLID, FLOWED BACK FROM THE SUCTION OPENING AND ENTERED THE PATIENTS EYE. THE FOREIGN MATERIAL WAS REMOVED FROM THE EYE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACKUP AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269490 DISPOSABLE 23GA VITRECTOMY CUTTER VITRECTOMY, INSTRUMENT CUTTER MLZ KIRWAN NGP0023 60466712 05050474534100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown