BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11972060 · Received June 9, 2021

    Report

    Report Number
    9610877-2021-00124
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Report Date
    August 20, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Additional Manufacturer Narrative · 0

    MDR 9610877-2021-00124 WAS A DUPLICATE OF THE MANUFACTURING REPORT SUBMITTED ON JULY 21, 2021 UNDER MDR 9610877-2021-10192. FOLLOWUP 01 REPORT FOR MDR 9610877-2021-00124 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE JUNE 09, 2021 INITIAL SUBMISSION. PLEASE REFER TO MDR 9610877-2021-10192.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 10-MAY-2021 OF A "BRUSH STUCK/BROKEN IN CHANNEL" INVOLVING THE PENTAX MEDICAL VIDEO COLONOSCOPE, MODEL EC38-I10L, SERIAL NUMBER (B)(4). THE FACILITY RESPONDED TO THE CUSTOMER SERVICE GOOD FAITH EFFORT(GFE) EMAIL ON 10-MAY-2021 AND STATED THAT IT WAS DIFFICULT TO PASS THE BRUSH THROUGH THE ENDOSCOPE THE CUSTOMER OWNED ENDOSCOPE WAS RETURNED FOR EVALUATION ON 18-MAY-2021. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND A "BROKEN ACCESSORY BLOCKING BIOPSY T-PIECE" CONFIRMING THE CUSTOMER'S EXPERIENCE OF RESISTANCE AND ALSO DOCUMENTED THE FOLLOWING ON 18-MAY-2021: PASSED DRY LEAK TEST, SUCTION TUBE RESISTANCE, PASSED WET LEAK TEST, CONTROL BODY GRIP SCRATCHED, UMBILICAL CABLE,MILD CRUSH, PVE CONNECTOR HOUSING SCRATCHED. ANOTHER GFE WAS SENT ON 18-MAY-2021 TO SEE IF THE USER FACILITY WAS AWARE OF ANY STUCK ACCESSORY. BASED ON THE USER'S RESPONSES, AND THE REPROCESSOR WAS ONLY EXPERIENCING RESISTANCE AND WAS UNAWARE OF THE "BROKEN ACCESSORY BLOCKING BIOPSY T-PIECE". THE USER FACILITY DID CONFIRM THAT THERE WAS NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN A PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION AND THAT THE ENDOSCOPE WAS REMOVED FROM CIRCULATION AND SENT FOR SERVICE. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, DISTAL END ASSY WITH TUBES, BENDING RUBBER, RL PULLEY ASSY, UD PULLEY ASSY, ADJUSTING COLLAR, ANGLE WIRE, SUCTION CHANNEL LG, O-RING (1.8X19.8). INSTRUCTIONS FOR USE(IFU), INCLUDES THE FOLLOWING WARNING SECTION "AFTER USING OPERATIONAL/CLEANING ACCESSORIES (E.G., FORCEPS, NEEDLES, SNARES, BRUSHES ETC.) WITH THE ENDOSCOPE, CAREFULLY CHECK THAT ALL ACCESSORIES ARE INTACT AND THAT NO PARTS HAVE FALLEN OFF AND BECOME LODGED WITHIN THE ENDOSCOPE'S INSTRUMENT/SUCTION CHANNEL. FURTHERMORE, ENSURE THAT ANY THERAPEUTIC DEVICES (E.G., CLIPS, STENTS, ETC.) PASSED THROUGH THE CHANNEL ARE ACCOUNTED FOR AFTER USE. ON 06-APR-2016, PENTAX ISSUED A U.S. URGENT FIELD CORRECTION WHICH IS AN IFU ADDENDUM FOR ENDOSCOPES WITH INSTRUMENT CHANNELS. THIS ADDENDUM COVERS ANY OPERATIONAL/CLEANING ACCESSORIES AND THERAPEUTIC DEVICES WHICH CAN BECOME LODGED IN THE ENDOSCOPE'S INSTRUMENT CHANNEL. IT REMINDS CUSTOMERS TO CAREFULLY CHECK THAT ALL ACCESSORIES ARE INTACT, THAT NO PARTS HAVE FALLEN OFF AND BECOME LODGED WITHIN THE ENDOSCOPE'S INSTRUMENT/SUCTION CHANNEL AND TO ENSURE THAT ANY THERAPEUTIC DEVICES (E.G., CLIPS, STENTS, BALLOONS, ETC.) PASSED THROUGH THE INSTRUMENT CHANNEL AND ARE ACCOUNTED FOR AFTER USE. PENTAX MEDICAL MODEL EC38-I10L, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 03-MAY-2019. THE ENDOSCOPE IS AWAITING REPAIR AND APPROVED BY FINAL QC AS 09-JUN-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867545 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1