BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEVIEW ENDOSCOPIC SOFT TISSUE RELEASE SYSTEM

    MDR report key: 7108284 · Received December 11, 2017

    Report

    Report Number
    MW5073901
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 30, 2017
    Manufacturer
    MISSION SURGICAL INNOVATIONS
    Product Code
    EMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING COURSE OF ENDOSCOPIC CARPAL TUNNEL RELEASE, BLADE BROKE OFF IN PT'S WRIST. ALL PARTS RETRIEVED. PROCEDURE COMPLETED WITHOUT FURTHER COMPLICATIONS OR HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886085 SAFEVIEW ENDOSCOPIC SOFT TISSUE RELEASE SYSTEM BLADE, ORTHOPEDIC SURGICAL INSTRUMENT EMF MISSION SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR