BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM

    MDR report key: 6718985 · Received July 17, 2017

    Report

    Report Number
    2083544-2017-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    November 10, 2016
    Report Date
    May 25, 2017
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IDZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOAM IS INSERTED IN THE CASSETTE AS A CONVENIENCE FOR THE LAB TECHNICIANS. DUE TO THE NATURE OF THE FOAM, THE FOAM MAY DETACH FROM THE CASSETTE LID. AS SUCH SAKURA HAD ADDED A WARNING LABEL TO EACH BOX AS AN ADDITIONAL SAFETY FACTOR TO FURTHER WARN THE USER TO ENSURE THE FOAM IS IN PLACE BEFORE USE. FURTHERMORE, IT IS REQUIRED BY THE OPERATING MANUAL, AND TRAINING PROVIDED TO THE TECHNICIANS TO PLACE THE TISSUE ON THE FOAM IN ORDER TO ENSURE THE PRESENCE OF THE FOAM. TECHNICIANS ARE AWARE OF THIS AS THIS INFORMATION IS PRESENT IN THE INSTRUCTIONS FOR USE AND IT IS ALSO A SUBJECT DURING REQUIRED HANDS ON TRAINING.

    Description of Event or Problem · 1

    ON (B)(6) 2017, SAKURA FINETEK USA, INC. WAS NOTIFIED THAT A USER SITE IN THE (B)(6) REPORTED AN INCIDENT WHICH OCCURRED ON (B)(6)2016 AND INVOLVED SAKURA'S PARAFORM 13X13 CASSETTE. SITE STATED THAT ONE GASTRIC BIOPSY CONTAINING 3 FRAGMENTS, ALL 2 MM, WAS LOST DURING PROCESSING AND NO TISSUE WAS MADE AVAILABLE FOR HISTOLOGICAL EXAMINATION BECAUSE THE LAB TECHNICIAN DID NOT VERIFY PRESENCE OF THE FOAM INSIDE THE CASSETTE DURING EMBEDDING PROCESS. FURTHERMORE, THE LAB TECHNICIAN FAILED TO FOLLOW THE INSTRUCTION OF PLACING TISSUE ON THE FOAM, AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE ENDOSCOPIC REPORT WAS ISSUED, STATED THAT THE TISSUE WAS LOST DURING PROCESSING, THEREFORE, NO HISTOLOGICAL ASSESSMENT COULD BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500343 TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM BIOPSY CASSETTE IDZ SAKURA FINETEK USA, INC. PM16165D03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other