BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RI WITNESS,SIT ON TOP,

    MDR report key: 8798423 · Received July 17, 2019

    Report

    Report Number
    1216677-2019-00203
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 5, 2019
    Report Date
    December 17, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQG
    PMA / PMN Number
    K160504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: (B)(4). *INVESTIGATION: X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS: TWO YEAR HISTORY REVIEWED - SHOWS NO SIMILAR ISSUES. DHR REVIEWED, NO ISSUES REPORTED. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND NO PROBLEMS WERE FOUND (REPORT ATTACHED), THE COMPLAINT COULD NOT BE REPLICATED OR CONFIRMED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. CORRECTIVE ACTIONS: *CORRECTION AND/OR CORRECTIVE ACTION: THIS COMPLAINT CONDITION IS CONSIDERED A LEVEL 4 CORRECTIVE ACTION PER BSR-QAR-026. LEVEL 4 COMPLAINTS WILL BE REVIEWED AND ADDRESSED IN COOPERSURGICAL'S CONTINUOUS IMPROVEMENT PROGRAM (CIP). SERVICE TECHNICIAN MADE AWARE OF CURRENT PRACTICE. NO RE-TRAINING AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    "PER E-MAIL REPORT- : EHP NOT READING TAGS IN THE CORNER OF THE HEATED GLASS. WORK AREA KEEPS SAYING THE DISH HAS BEEN REMOVED. LATEST VERSION OF RFID MODULE AND WORK AREA INSTALLED AND PROBLEM PERSISTS. NEW EHP NEEDED." REF: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "PER E-MAIL REPORT : EHP NOT READING TAGS IN THE CORNER OF THE HEATED GLASS. WORK AREA KEEPS SAYING THE DISH HAS BEEN REMOVED. LATEST VERSION OF RFID MODULE AND WORK AREA INSTALLED AND PROBLEM PERSISTS. NEW EHP NEEDED." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593535 RI WITNESS,SIT ON TOP, RI WITNESS,SIT ON TOP, MQG COOPERSURGICAL, INC. 6-70-807 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other