BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETCAM SHUTTLE

    MDR report key: 5394963 · Received January 27, 2016

    Report

    Report Number
    2952489-2016-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    September 17, 2015
    Report Date
    October 20, 2015
    Manufacturer
    CLARITY MEDICAL SYSTEMS, INC.
    Product Code
    HKI
    PMA / PMN Number
    K090326
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER, (B)(6) HOSPITAL MEDICAL CENTER, PURCHASED A RETCAM SHUTTLE SYSTEM (RS 6401) AND ROP LENS (MODEL D1300 SERIAL (B)(4)) IN (B)(6) 2014. THE UNIT WAS INSTALLED ON (B)(4) 2014. USER TRAINING WAS PERFORMED BY CLARITY PERSONNEL ON MAY 2, 2014. THE UNIT WAS PROVIDED WITH A RETCAM SHUTTLE USER MANUAL (P/N 18-000393 REV A). ON JUNE 30, 2015, (B)(6) CALLED INTO CLARITY THAT "THE SEAM ALONG THE TOP OF THE CAMERA IS SPLITTING.". NEW HANDPIECE COVERS WERE SUBSEQUENTLY PROVIDED TO (B)(6). THERE WERE NO PATIENT INJURIES. PICTURES OF THE SUSPECT HANDPIECE WERE AVAILABLE FOR REVIEW. THE ALLEGED CRACKS WERE CONFIRMED AND THE CRACKS WERE INDICATIVE OF A MECHANICAL FRACTURE AND NOT CHEMICAL CRAZING. THE RETCAM HANDPIECE IS NOT INTENDED AND IS UNLIKELY TO CONTACT THE PATIENT EYE OR MUCOUS MEMBRANES. THE CLARITY USER MANUAL INFORMS THE USER TO USE GOOD PUBLIC HEALTH PRACTICES WHEN HANDLING THE EQUIPMENT, BASED ON CDC GUIDELINES. THE (B)(6) SUGGEST CLEANING INSTRUMENTS (THAT MAY COME INTO CONTACT WITH PATIENTS) WITH ALCOHOL OR BLEACH AND DOES NOT MENTION DISINFECTION. (B)(4) WERE SUGGESTED TO THE CUSTOMER FOR USE. WE RECEIVED AN E-MAIL FROM (B)(6) ON 10/28/2015 THAT THE HANDPIECE WITH THE REPLACED SHELLS IS WORKING FINE. CLARITY CONSIDERS THE MATTER CLOSED. (B)(4).

    Description of Event or Problem · 1

    DIGNITY HEALTH REPORTED THROUGH MEDWATCH, ISSUE WITH RETCAM HANDPIECE. CAMERA HANDSET WAS NOTED TO HAVE SPLITTING AT THE SEAM AND CRACKING RUNNING OFF FROM THE SEAM. MOREOVER, THE HOSPITAL INFECTION CONTROL DEPARTMENT NEEDS HIGH LEVEL DISINFECTION FOR ALL MEDICAL INSTRUMENTS THAT COME IN CONTACT WITH MUCOUS MEMBRANES AND THE RETCAM INSTRUCTIONS FOR USE (IFU) DOES NOT PROVIDE DISINFECTANTS THAT COULD BE USED ON THE MACHINE INCLUDING THE HANDSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51778 RETCAM SHUTTLE OPHTHALMIC CAMERA HKI CLARITY MEDICAL SYSTEMS, INC. RETCAM SHUTTLE

    Patients

    Seq Age Sex Outcome Treatment
    1