BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 11905729 · Received May 29, 2021

    Report

    Report Number
    9610877-2021-00127
    Event Type
    Injury
    Date Received
    May 29, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 2, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G6: FOLLOW UP #01. ADDITIONAL INFORMATION: D9. DEVICE NOT AVAILABLE FOR RETURN. G2: CANADIAN. H3: DEVICE NOT RETURNED TO MANUFACTURER. H6 CONTINUED: TYPE OF INVESTIGATION: 4114 DEVICE NOT RETURNED . INVESTIGATION FINDINGS: 3221 NO FINDINGS AVAILABLE. INVESTIGATION CONCLUSIONS: 25 CAUSE TRACED TO MANUFACTURING. ON 31-MAY-2021, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EC38-I10NL, SERIAL NUMBER (B)(6) WAS PERFORMED UNDER IVAI-21-050043. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED AT THE MIYAGI FACILITY ON 28-NOV-2019 THE SUBSTRATE WAS REPLACED AS PART OF A REWORK. THERE WERE NO CONCESSIONS AND THE DEVICE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 29-NOV-2019. ALTHOUGH THE ENDOSCOPE WAS NOT RETURNED FOR EVALUATION, THE MANUFACTURING SITE DOCUMENTED MANUFACTURING AS THE ROOT CAUSE OF THE MALFUNCTION. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Additional Manufacturer Narrative · 1

    THIS MODEL IS NOT RELEASED FOR SALE IN THE UNITED STATES, ITS ONLY IMPORT FOR EXPORT. (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 29-APR-2021 THAT OCCURRED IN (B)(6). THE INFORMATION PROVIDED INDICATED THAT THERE WAS A SUBTLE BLURRY LENS. THE ISSUE WAS OBSERVED DURING USE IN THE OPERATING ROOM AND DID NOT IMPACT THE IMAGE TO A LARGE EXTENT, BUT THE IMAGE SEEMED OUT OF FOCUS. THE ISSUE WAS OBSERVED USING PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10NL, SERIAL NUMBER (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN A PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS INITIALLY REPORTED. PER THE INSTRUCTIONS FOR USE (IFU); BEFORE USE, THE INSTRUMENT, ACCESSORIES, VIDEO PROCESSOR, AND OTHER COMPONENTS MUST BE PREPARED AND CAREFULLY INSPECTED ACCORDING TO THE IFU. AN INSTRUMENT WITH SUSPECTED ABNORMALITY SHOULD BE ASSESSED WITH REFERENCE TO THE "TROUBLESHOOTING GUIDE". IF THE PROBLEM PERSISTS AFTER TROUBLESHOOTING OR THERE IS AN APPARENT FAILURE, DO NOT USE THE INSTRUMENT; SEND IT FOR REPAIR. BASED ON RESPONSES TO ADVERSE EVENT QUESTIONS SENT TO THE CUSTOMER AND PROVIDED ON 10-MAY-2021, THE USER FACILITY RESPONDED STATING THAT THE ENDOSCOPE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY OR RISK OF CROSS CONTAMINATION. WHILE THE PATIENT STATUS IS NOTED AS OK AND THEY DID NOT REPORT ANY INJURY TO THE PATIENT AND THE PATIENT IS NOT BEING RECALLED FOR FURTHER SCREENING, THEY DID MENTION THAT THE PATIENT HAD PAIN DURING THE PROCEDURE. THE INVESTIGATION IS IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802104 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10NL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other