BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5133679 · Received October 7, 2015

    Report

    Report Number
    9610877-2015-00007
    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
    ITX
    PMA / PMN Number
    K961974
    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 EG-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 EG-3630U/SERIAL. PENDING RETURN OF DEVICE.

    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). REPORTING ADVERSE EVENT ONLY AS A PRODUCT MALFUNCTION DID NOT OCCUR WITH THE DEVICE INVOLVED IN THIS EVENT. TYPE OF REPORTABLE EVENT CORRECTED TO SERIOUS INJURY.

    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 (B)(4)). 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 (B)(6) 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

    ON 11/12/2015, PENTAX (B)(4) CONFIRMED THAT THE ULTRASOUND GASTROSCOPE WAS RETURNED ON 09/21/2015 UNDER (B)(4) FOR EVALUATION. THE EVALUATION INSPECTION REVEALED THAT THIS SCOPE WAS IN NEED OF REPAIR DUE TO FAILURES IN THE ULTRASOUND IMAGE, LOOSE TRANSDUCER AT DISTAL BODY, FRAYED ELEVATOR WIRE AND BUCKLE AT ULTRASOUND CONNECTOR CABLE LONG NEAR JUNCTION ROOT BRACE. THE FAILURES COULD NOT HAVE CAUSE OR CONTRIBUTED TO THE BRUSH BREAKING IN THE CHANNEL. THE BIOPSY CHANNEL PASSED ALL INSPECTIONS. THE ULTRASOUND GASTROSCOPE IS CURRENTLY AT PENTAX (B)(4) AWAITING APPROVAL OF THE REPAIR ESTIMATE PROVIDED TO THE CUSTOMER. 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 SHOULD NOT BE USED TOGETHER, A DEVICE MALFUNCTION DID NOT OCCUR ACCORDING TO 21 CFR 803. A DEVICE HISTORY REVIEW WAS PERFORMED ON 09/25/2015 CONFIRMING THE ULTRASOUND GASTROSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. 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. (B)(4\).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662292 PENTAX LINEAR ULTRASOUND VIDEO GASTROSCOPE ITX HOYA CORPORATION PENTAX TOKYO OFFICE EG-3630U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention