BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE-TEK CRYO3 FLEX, 115V D

    MDR report key: 9914538 · Received April 1, 2020

    Report

    Report Number
    2083544-2020-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    February 10, 2020
    Report Date
    July 8, 2020
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED UNIT REVEALED THAT THE SSR (SOLID STATE RELAY) WAS SLOWLY OVERHEATED AND EVENTUALLY BURNED. THE SURROUNDING COMPONENTS, SUCH AS AIR COMPRESSOR, COOLING FAN, CIRCUIT BREAKER, AC LINE FILTER, ETC., WHICH MAY HAVE DIRECT OR INDIRECT EFFECT ON THE SSR'S PERFORMANCE WERE EVALUATED; NO ISSUE WAS IDENTIFIED, THUS, ELIMINATED AS A CONTRIBUTING FACTOR OR CAUSE OF THE EVENT. THE INVESTIGATION OF THE LOG FILE REVEALED THAT THE SSR (SOLID STATE RELAY), WHICH NORMALLY TURNS ON/OFF THE AC INPUT TO THE COMPRESSOR, HAD AN INTERNAL ISSUE AS INDICATED ON THE LOG FILE SINCE 1/19/20. IT WAS NOT ABLE TO TURN OFF THE COMPRESSOR WHEN THE COMPRESSOR WAS COMMANDED TO DO SO BY THE SW. THE SSR WAS OVERHEATED AND EVENTUALLY BURNED, THUS, SAKURA WAS NOT ABLE TO DETERMINE EXACTLY WHAT INTERNAL ISSUE THE SSR HAD. THE DEVICE WAS DESIGNED, TESTED AND CERTIFIED BY INTERTEK, A GLOBAL PRODUCT QUALITY TESTING ORGANIZATION, TO BE IN COMPLIANCE WITH THE IEC 61010-1:2010, WHICH INCLUDES THE REQUIREMENTS IN CLAUSE 9 FOR PROTECTION AGAINST THE SPREAD OF FIRE. THE DAMAGE WAS WHOLLY CONTAINED WITHIN THE INSIDE OF THE DEVICE AS DESIGNED. IF THIS MALFUNCTION OCCURS, THE FIRE IS CONTAINED WITHIN THE MAIN POWER BOX AND WILL NOT IMPACT OTHER PARTS OF THE DEVICE. THIS IS CONSIDERED AN ISOLATED COMPONENT FAILURE. THIS IS THE ONLY INCIDENT OF THIS TYPE SINCE THE LAUNCH OF THIS DEVICE IN 2016. (B)(4).

    Description of Event or Problem · 0

    SAKURA FINETEK USA, INC., RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH CUSTOMER STATED THAT A SMELL OF SMOKE CAME OUT FROM THE BACK OF THE UNIT ON (B)(6) 2020 WHEN IT WAS IDLE AND NOT IN USE. THE TECHNICIAN IN THE LAB SHUT THE UNIT OFF AND AIRED OUT THE ROOM. THIS CAUSED THE SSR (SOLID STATE RELAY) AND RIBBON CABLES TO SEVERELY BURN AND MELT. THE INCIDENT OCCURRED AFTER THE DAILY AUTO OZONE DISINFECTION CYCLE ENDED WHILE THE DEVICE WAS NOT IN USE BY THE OPERATOR, AND NO PATIENT TISSUES WERE DAMAGED AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THE SAKURA INVESTIGATION OF THE LOG FILE REVEALED THAT THE SSR (SOLID STATE RELAY), WHICH NORMALLY TURNS ON/OFF THE AC INPUT TO THE COMPRESSOR, HAD AN INTERNAL ISSUE AS INDICATED ON THE LOG FILE SINCE 1/19/2020. IT WAS NOT ABLE TO TURN OFF THE COMPRESSOR WHEN IT WAS COMMANDED TO DO SO BY THE SW. THE SSR WAS OVERHEATED AND EVENTUALLY BURNED, THUS, SAKURA IS NOT ABLE TO DETERMINE EXACTLY WHAT INTERNAL ISSUE THE SSR HAD. THE INCIDENT OCCURRED AFTER THE DAILY AUTO OZONE DISINFECTION CYCLE ENDED WHILE THE DEVICE WAS NOT IN USE BY THE OPERATOR, AND NO PATIENT TISSUES WERE DAMAGED AS A RESULT OF THIS INCIDENT. THE DEVICE WAS DESIGNED TO MEET THE REQUIREMENTS OF THE IEC 61010-1:2010, SPECIFICALLY THE REQUIREMENT OF CLAUSE 9 PROTECTION AGAINST THE SPREAD OF FIRE. THE FIRE/FLAME DID NOT SPREAD OUTSIDE OF THE DEVICE, WAS CONTAINED WITHIN THE INSIDE OF THE DEVICE AS DESIGNED. THIS IS CONSIDERED AN ISOLATED COMPONENT FAILURE; SAKURA HAS NOT SEEN SUCH FAILURE SINCE THE CRYO3 FLEX WAS INTRODUCED IN 2016.

    Description of Event or Problem · 1

    SAKURA FINETEK USA, INC., RECEIVED A COMPLAINT ON 02/11/2020 IN WHICH CUSTOMER STATED THAT UNIT STARTED ON FIRE FROM THE BACK ON (B)(6) 2020 WHEN IT WAS IDLE AND NOT IN USE. THE TECHNICIAN IN THE LAB SHUT THE UNIT OFF AND AIRED OUT THE ROOM. THE FIRE CAUSED THE SSR (SOLID STATE RELAY) AND RIBBON CABLES TO SEVERELY BURN AND MELT. THERE WAS NO DAMAGE TO THE PATIENT TISSUE SAMPLES, OR INJURY TO THE USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372562 TISSUE-TEK CRYO3 FLEX, 115V D CRYO3 FLEX IDO SAKURA FINETEK USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other