BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOPPER AMBIDEXTROUS SEIBEL

    MDR report key: 20110374 · Received August 30, 2024

    Report

    Report Number
    0001920664-2024-00109
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 8, 2024
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HNQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS INSTRUMENT IS MANUFACTURED FROM A SINGLE PIECE OF RAW MATERIAL - THERE ARE NO ASSEMBLED COMPONENTS - THE TIP IS NOT ATTACHED BY WELD, SOLDER OR ANY OTHER MEANS. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SEE RELATED REPORT: 0001920664-2024-00110.

    Description of Event or Problem · 0

    A USER FACILITY IN THE UNITED STATES REPORTED THAT ONE MONTH AFTER A ROUTINE CATARACT SURGERY A LITTLE METALLIC SPECK WAS SEEN IN THE PATIENT¿S RIGHT EYE. ALTHOUGH THIS WAS NOT OBSERVED ON THE POSTOP DAY 1 VISIT, IT MAY SIMPLY HAVE BEEN OVERLOOKED OR MIGRATED AFTER DAY 1. AT NO POINT WAS ANY METAL OBSERVED DURING SURGERY. THE USER IS UNABLE TO CONFIRM THE SOURCE OF THE PARTICLE. THERE WAS NO COMPLICATIONS NOR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097304 CHOPPER AMBIDEXTROUS SEIBEL HANDHELD SURGICAL INSTRUMENT HNQ BAUSCH + LOMB E0590 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown