BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 25154700 · Received May 12, 2026

    Report

    Report Number
    0002090040-2026-00012
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    February 9, 2026
    Report Date
    May 12, 2026
    Manufacturer
    STRYKER-ENDOSCOPY PHOENIX USA
    Product Code
    NLH
    UDI-DI
    00885825009557
    PMA / PMN Number
    K112232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED CATHETER PRODUCED S CURVE INSTEAD OF A U CURVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577385 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER-ENDOSCOPY PHOENIX USA 81104 5602490SH 00885825009557

    Patients

    Seq Age Sex Outcome Treatment
    1