BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAPHYRE II, 90 DEG HP

    MDR report key: 652701 · Received December 9, 2005

    Report

    Report Number
    1216828-2005-00047
    Event Type
    Other
    Date Received
    December 9, 2005
    Date of Event
    November 1, 2005
    Report Date
    December 9, 2005
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SHOULDER ARTHROSCOPY A LARGE ARC WAS GENERATED FROM DISTAL TIP TO RETURN COLLAR OF PROBE. SURROUNDING MUSCLE AND SOFT TISSUE WAS SEARED. THE SETTINGS OF THE GENERATOR USED WAS DEFAULT SETTINGS.NO OTHER INFORMATION IS AVAILABLE FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPHYRE II, 90 DEG HP PROBE HRX SMITH & NEPHEW, INC., ENDOSCOPY DIVISION 7210112 4449824

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other