BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 17181745 · Received June 22, 2023

    Report

    Report Number
    2518897-2023-00036
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    May 12, 2023
    Report Date
    August 21, 2023
    Manufacturer
    HOYA CORPORATION PENTAX
    Product Code
    FDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION B4: DATE OF THIS REPORT. B5. REFER TO H10. F7: FOLLOW UP #01. F11: UPDATED DATES. F13: UPDATED DATES. ADDITIONAL INFORMATION. D4: UNIQUE IDENTIFIER (UDI) CORRECTED. D8: DEVICE REPAIRED BY THIRD PARTY. F9: AGE OF DEVICE. F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING COMPONENT CODE: ADDED COMPONENT CODE: 866 LENSES. THE PENTAX MEDICAL ENGINEER CHECKED WITH THE HOSPITAL STAFF AND THE DEVICE WAS USED FOR EXAMINATION WITH NO HARM CAUSED TO THE PATIENT. THE EXAMINATION WAS COMPLETED WITH ANOTHER DEVICE. THEY NOTED THAT THE OBJECTIVE LENS WAS BROKEN AND DIRTY WHICH CAUSED BLURRY IMAGE. A PAINLESS EXAMINATION WAS REPORTEDLY DONE FOR THE PATIENT USING TWO ENDOSCOPES WITHIN THE ONE EXAMINATION. THE FIRST ENDOSCOPE WAS THE ONE WITH THE REPORTED DEFECT AND CAPTURED WITHIN THIS REPORT. THE SECOND ENDOSCOPE, SAME MODEL, UNKNOWN SERIAL NUMBER, WAS USED TO COMPLETED THE EXAMINATION. THE DIETARY RESTRICTION IMPLEMENTED WERE DUE TO THE PATIENT'S ILLNESS AND HAS NOTHING TO DO WITH THE REPORTED INTESTINAL MUCOSA DAMAGE. THE DEVICE WAS REPAIRED BY THE THIRD PARTY AND RETURNED TO THE HOSPITAL. BASED ON THE CONTENT OF INVESTIGATED DATA, IT WAS DETERMINED THAT THE POTENTIAL CAUSE/ROOT CAUSE OF FAILURE WAS THAT THE IMAGE WAS BLURRY DUE TO DAMAGE TO THE OBJECTIVE LENS, BUT THE FACILITY WAS ASKING A THIRD PARTY TO REPAIR IT, SO THE CAUSE COULD NOT BE DETERMINED. WE REMINDED THE HOSPITAL THAT THEY SHOULD PAY ATTENTION TO DAILY CHECK WHICH CAN REDUCE THE OCCURRENCE OF ACCIDENTS. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED AT THE PENTAX MEDICAL MIYAGI ON 27-DEC-2019 UNDER NORMAL CONDITIONS. THE ENDOSCOPE WAS REWORKED FOR "LABELING DEFECT" AND "PASSED AT THE SECOND INSPECTION" AND PASSING THE NECESSARY INSPECTIONS INCLUDING THE REPLACEMENT OF THE UDI PLATE, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 27-DEC-2019. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Additional Manufacturer Narrative · 0

    F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 1946 LACERATION(S), 1888 HEMORRHAGE/BLEEDING HEALTH EFFECT IMPACT CODE: 4638 ENDOSCOPIC PROCEDURE, 4613 MINOR INJURY/ILLNESS/IMPAIRMENT MEDICAL DEVICE PROBLEM CODE: 1408 POOR IMAGE QUALITY COMPONENT CODE: 841 IMAGER; WE RECEIVED A GOOD FAITH EFFORT(GFE) RESPONSE VIA EMAIL ON 16-JUN-2023 AND 21-JUN-2023 THAT THE ORIGINAL ENDOSCOPE USED WAS THE CAUSE OF THE INJURY, AND A REPLACEMENT ENDOSCOPE WAS THEN USED TO COMPLETE THE EXAMINATION. THE PATIENT HAD NO SIDE EFFECTS AND WAS DISCHARGED THE SAME DAY. WE ALSO RECEIVED RESPONSES THAT THE CAUSE OF DIETARY RESTRICTIONS WAS THE PATIENT'S ILLNESS. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. FILE ATTACHMENTS.

    Description of Event or Problem · 0

    REFER TO H10.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT HE HAD EPIGASTRIC PAIN AFTER EATING WITH NO OBVIOUS CAUSE A WEEK AGO, WITH CONTINUOUS ROWS OF VAGUE PAIN, AND BLACK STOOLS 5 TIMES AFTER TAKING GASTRIC MEDICINE (SPECIFIC DESCRIPTION UNCLEAR) ON (B)(6) 2023 WITH AN AMOUNT OF ABOUT 100G EACH TIME, AND THE DOCTOR DIAGNOSED: PEPTIC ULCER? GASTRITIS? THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 19:58 ON (B)(6) 2023. THE PATIENT WAS GIVEN A PAINLESS GASTROSCOPY AT 10:05 ON (B)(6) 2023 TO IDENTIFY THE CAUSE OF THE REPORTED PAIN..GASTROSCOPE MODEL EC38-I10M, SERIAL NUMBER (B)(6) WAS USED INITIALLY. DURING THE EXAMINATION, THE ENDOCOPE LENS WAS FOUND TO BE BLURRED AND COULD NOT SEE THE TUBULAR ADENOMA OF THE INTESTINAL MUCOSAL LAYER BELOW 0.5 CM. THE ENDOSCOPE WAS REPLACED WITH ANOTHER ONE TO USE IMMEDIATELY, UNKNOWN MODEL AND SERIAL NUMBER, AND THE FIELD OF VIEW WAS CLEAR AFTER THE REPLACEMENT. DUE TO TWO TIMES OF ENTERING AND WITHDRAWING THE ENDOSCOPES, THE INTESTINAL MUCOSA WAS DAMAGED RESULTING IN MILD BLEEDING. THE PATIENT WAS INSTRUCTED TO EAT A COLD OR LIQUID DIET BELOW 30 DEGREES ON THE SAME DAY. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969625 PENTAX VIDEO COLONO SCOPE FDF HOYA CORPORATION PENTAX EC38-I10M

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other