BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMANUFACTURED SCISSOR

    MDR report key: 25135226 · Received May 11, 2026

    Report

    Report Number
    25135226
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 23, 2026
    Manufacturer
    RESTORE ROBOTICS REPAIRS LLC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD WAS USING THE NEW ENCORE REPROCESSED SCISSOR, IT WAS DULL AND WOULD NOT CUT. THIS WAS THE SECOND USE OF THE INSTRUMENT. REMOVED FROM FIELD AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510503 REMANUFACTURED SCISSOR SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY RESTORE ROBOTICS REPAIRS LLC 470179 K12250306 0673

    Patients

    Seq Age Sex Outcome Treatment
    1