BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5133660 · Received October 7, 2015

    Report

    Report Number
    9610877-2015-00006
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR 9610877-2015-00006 IS BEING SUBMITTED FOR PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0041075. MDR 9610877-2015-00007 IS BEING SUBMITTED FOR PENTAX ULTRASOUND GASTROSCOPE MODEL 3630U/SERIAL (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MDR 9610877-2015-00006 IS BEING SUBMITTED FOR PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0041075. MDR 9610877-2015-00007 IS BEING SUBMITTED FOR PENTAX ULTRASOUND GASTROSCOPE MODEL 3630U/SERIAL (B)(4). PENDING DEVICE RETURN, IF AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MDR 9610877-2015-00006 IS BEING SUBMITTED FOR PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0041075. MDR 9610877-2015-00007 IS BEING SUBMITTED FOR PENTAX ULTRASOUND GASTROSCOPE MODEL EG-3630U/SERIAL (B)(4). THE DEVICE INVOLVED IN THIS EVENT WAS DISCARDED BY THE FACILITY. DEVICE DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    ON 09/10/2015, PENTAX MEDICAL RECEIVED A REPORT STATING "A 4-INCH PIECE OF A BROKEN BRUSH (PENTAX MODEL CS-6021T/LOT 0041075) WAS PUSHED OUT OF THE BIOPSY CHANNEL INTO THE PATIENT WHILE INSERTING A EUS NEEDLE DOWN THE CHANNEL OF A PENTAX EUS SCOPE (MODEL EG-3630U/SERIAL E01041). THE PHYSICIAN RETRIEVED THE PIECE OF THE CLEANING BRUSH AND THERE WAS NO REPORT OF INJURY TO THE PATIENT". GOOD FAITH EFFORT ATTEMPTS WERE MADE VIA E-MAIL ON 09/14/2015 AND 10/01/2015 TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, INCLUDING STATUS OF PRODUCT RETURN. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. THE INSTRUCTIONS FOR USE FOR ULTRASOUND GASTROSCOPE MODEL EG-3630U CLEARLY STATES TO USE THE LONG THICK CLEANING BRUSH PROVIDED (MODEL # CS-6021SN) FOR MECHANICAL CLEANING OF THE ULTRASOUND GASTROSCOPE. FURTHERMORE, ULTRASOUND GASTROSCOPE MODEL EG-3630U IS NOT ON THE COMPATIBLE LIST OF ENDOSCOPES IN THE INSTRUCTION FOR USE FOR CLEANING BRUSH MODEL # CS-6021T. THEREFORE, IT IS CLEAR THAT THE BRUSH INVOLVED IN THIS EVENT (MODEL # CS-6021T) IS NOT COMPATIBLE FOR USE WITH ULTRASOUND GASTROSCOPE MODEL EG-3630U.

    Description of Event or Problem · 1

    GOOD FAITH EFFORT ATTEMPTS WERE MADE VIA EMAIL ON 09/14/2015 AND 10/01/2015 TO PENTAX CANADA TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, INCLUDING STATUS OF PRODUCT RETURN. PENTAX (B)(4) INDICATED THE PRODUCT WAS DISCARDED BY THE FACILITY, AND THE FACILITY HAD NO ADDITIONAL INFORMATION TO PROVIDE REGARDING THE EVENT. AS PER THE INVESTIGATION COMPLETED BY PENTAX MEDICAL ON 11/13/2015, USER ERROR WAS REVEALED TO BE THE CONTRIBUTING CAUSE OF THIS EVENT. IN ADDITION, SINCE THE LABELING MAKES IT CLEAR THAT THE DEVICES (PENTAX VIDEO GASTROSCOPE ULTRASOUND MODEL EG-3630U AND PENTAX TRI-BRISTLED CLEANING BRUSH MODEL CS-6021T) SHOULD NOT BE USED TOGETHER, A DEVICE MALFUNCTION DID NOT OCCUR ACCORDING TO 21 CFR 803. A DEVICE HISTORY REVIEW WAS PERFORMED ON 10/16/2015 WHICH INDICATED THE BRUSH WAS MANUFACTURED BY (B)(4) AND NO NON-CONFORMANCES WERE FOUND DURING FINAL INSPECTION. PENTAX OFFERED ADDITIONAL TRAINING TO THE CSR TECHNICIANS AROUND CLEANING AND CARE OF THE EUS SCOPE AND, IN ADDITION, THE INSTRUCTIONS FOR USE FOR THE PENTAX TRI-BRISTLED CLEANING BRUSH MODEL CS-6021T WAS PROVIDED TO THE FACILITY. MDR 15-00114 WAS FILED ON 09/08/2015 WITH HEALTH (B)(4). SINCE NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663504 PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS-6021T 0041075

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention