BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    MDR report key: 11325997 · Received February 14, 2021

    Report

    Report Number
    8010047-2021-02603
    Event Type
    Malfunction
    Date Received
    February 14, 2021
    Report Date
    June 19, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE SUBJECT DEVICE WHICH HAVE BEEN SENT ONLY INSERTION TUBE PART BY OLYMPUS EUROPE SE & CO. KG (OEKG) AND FOLLOWINGS WERE FOUND DURING INVESTIGATION; IT WAS CONFIRMED THE DAMAGE OF THE GLUING APPEARANCE OF THE OBJECT LENS. GLUE OF BOTH OF ON THE RIGHT AND LEFT LENS WAS CRACKED THROUGHOUT AND PARTIALLY CHIPPED AS OEKG REPORT SAID. IT WAS CONFIRMED THAT THE BENDING SECTION RUBBER ADHESIVE WAS CRACKED THROUGHOUT AND PARTIALLY CHIPPED AS WELL. MINOR SCRATCHES WERE FOUND ON THE INSERTION SECTION AND DISTAL END. HOWEVER, IT COULD NOT FIND EVIDENT DENT OR SCRATCH WHICH SEEMINGLY RESULTED FROM BEING HIT BY SOMETHING. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED ON THE INVESTIGATION, OMSC SURMISED THERE WAS THE POSSIBILITY THOSE PHENOMENA WERE ATTRIBUTED TO FOLLOWING CAUSES; SEVERE CHEMICAL DAMAGE WAS THOUGHT TO BE THE ASSUMABLE CAUSE OF THE DAMAGE OF THE GLUING APPEARANCE OF THE OBJECT LENS. ESPECIALLY, IT WAS CAUSED MAINLY BY CHEMICAL DAMAGE DUE TO PERFORMING STERRAD 100 NX ((A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR) WITH STANDARD CYCLE. BASED ON THE SIMILAR FORMER CASE HAVE BEEN REPORTED FROM OTHER FACILITY, IT HAD BEEN OCCURRED THE DETERIORATION AS A RESULT OF AUTOCLAVING BY MISTAKE (WITH CHEMICAL STRESS) SINCE ALMOST ALL GLUING PARTS OF THE SUBJECT DEVICE WERE CRACKED, IT WAS PRESUMED THAT SEVERE CHEMICAL STRESS APPLIED TO ALL OVER THE SUBJECT DEVICE. BASED ON THE REPORT OF OLYMPUS EUROPE SE & CO. KG (OEKG), THE SUBJECT DEVICE WAS REPROCESSED BY STERRAD 100 NX WITH STANDARD CYCLE WHICH IS NOT RECOMMENDED WAY FROM IFU, REPROCESSING MANUAL. THEREFORE, THE SUBJECT DEVICE MIGHT HAVE BEEN REPROCESSED BY UNSPECIFIED METHOD IN THE USER FACILITY. ADDITIONALLY, THE SUBJECT DEVICE MIGHT HAVE BEEN RECEIVED STRESS DUE TO MANUALLY WASHING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS BEEN NOT RETURNED TO OMSC FOR THE EVALUATION, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT IT WAS SEEMED THE BENDING SECTION RUBBER OF THE SUBJECT DEVICE WAS PEELED OFF INTO SMALL PIECES AT THE MAINTENANCE BEFORE THE UNSPECIFIED PROCEDURE. THE USER ALSO REPORTED THAT THE USER FACILITY¿S REPROCESS METHOD AS FOLLOWS; MAX 93 DEGREES DISINFECTION MUST LAST FOR 1MIN IN STERILIZATION. STERRAD 100NX (A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR) STANDARD PROGRAM WASHING LIQUID ERIZYME AND DOSAGE IS DONE BY THE MACHINE AUTOMATICALLY. DRYING CABINET 78 DEGREES APPROXIMATELY 15 MINUTES. AT THE INCOMING INSPECTION FOR THE REPAIR, THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE. IT WAS FOUND THE SERIOUS DETERIORATION CAUSING A SIGNIFICANT PEELING AND CRACKING OF THE BENDING SECTION RUBBER ADHESIVE CONDITION AND THE BAD GLUING APPEARANCE REGARDING THE LENSES AT THE DISTAL END AT THE FIRST VISUAL INSPECTION. IT WAS ALSO FOUND WITH THE LOUPE THAT THE CRUMBLING WITH DISCOLORATION OF THE LENSED GLUING WHICH MIGHT HAVE OCCURRED DURING THE REPROCESSING BY THE USER. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222841 ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S300-10-3D

    Patients

    Seq Age Sex Outcome Treatment
    1