BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 18667404 · Received February 8, 2024

    Report

    Report Number
    2518897-2024-00005
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    November 30, 2023
    Report Date
    February 7, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333248315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. EVALUATION SUMMARY BASED ON THE INVESTIGATION, DURING THE INSPECTION DEFECTS WERE DETECTED IN THE CABLE AND CCD CAMERA. A POTENTIAL ROOT CAUSE OF THESE FAILURES ARE PHYSICAL IMPACT (VIBRATION, DROP, SHOCK) OR FLUID DAMAGE TO CCD DRIVER PCB. PHYSICAL IMPACT (VIBRATION, DROP, SHOCK) OR FLUID DAMAGE TO CCD DRIVER PCB OCCURED IMAGE FAILURE. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED BY PENTAX MEDICAL MIYAGI ON 01-NOV-2022 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 AS 01-NOV-2022. PENTAX MEDICAL AMERICA PERFORMED GOOD FAITH EFFORT TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT AND PROVIDED AN EMAIL RESPONSE ON 11-JAN-2024 WITH THE FOLLOWING QUESTIONS. Q. WAS THE PROCEDURE FOR TREATMENT OR DIAGNOSTIC PURPOSES? A: TREATMENT. Q. WAS THE PATIENT ALREADY PREPPED FOR THE PROCEDURE? A :YES. Q: WAS THERE A DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION SUCH AS ADDITIONAL ANESTHESIA OR PROLONGED HOSPITAL STAY? A: YES. Q: DID THE DELAY OR MEDICAL INTERVENTION PUT THE PATIENT AT RISK FOR ADVERSE EVENTS? A: YES. Q: IF THIS EVENT INVOLVES A STUCK ACCESSORY, DID THE ACCESSORY BECAME STUCK DURING THE CURRENT PROCEDURE? A: NO. Q: WAS THE PRODUCT USED TO COMPLETE THE PROCEDURE? A: NO. Q: WAS THE PROCEDURE COMPLETED WITH ANOTHER SIMILAR DEVICE? A: NO. Q: WAS THE PROCEDURE COMPLETED? A: NO. Q: IF THE PROCEDURE WAS CANCELLED, WAS THE PROCEDURE PERFORMED ON ANOTHER DAY? A: NO. RESCHEDULED PROCEDURE PENDING. Q: WAS THE PATIENT RECALLED FOR FURTHER SCREENING? A: NO. Q: WAS THE PRODUCT REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT? A: YES. IN RESPONSE TO THE ABOVE REPLY, PENTAX MEDICAL AMERICA ASKED THE CUSTOMER THE FOLLOWING QUESTIONS AGAIN TO GATHER FURTHER INFORMATION, BUT DID NOT RECEIVE A RESPONSE. Q: IT IS DESCRIBED AS A PROCEDURE FOR TREATMENT, BUT WHAT KIND OF TREATMENT DID THEY HAVE? Q: WHY COULDN'T THE PROCEDURE BE COMPLETED? I WOULD LIKE TO KNOW THE REASON, WHETHER IT WAS BECAUSE THEY DID NOT HAVE A REPLACEMENT SCOPE, THE PATIENT'S CONDITION, OR WHETHER THEY HAD ALREADY DETERMINED THAT THE PROCEDURE WAS NOT NECESSARY. Q : WHY DON'T YOU DO THE PROCEDURE ON ANOTHER DAY? SAME AS ABOVE, I WOULD LIKE TO KNOW THE REASON. Q: PATIENT'S CURRENT CONDITION. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    PENTAX OF AMERICA, INC. PERFORMED SEVERAL GOOD FAITH EFFORT ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING AN INITIAL CUSTOMER REPORTED ON 30-NOV-2023 OF AN IMAGE FAILURE DURING USE WITHOUT LEAK AND NO PATIENT HARM INVOLVING VIDEO GASTROSCOPE MODEL EG29-I10 SERIAL NUMBER (B)(6). THE USER FINALLY PROVIDED AN EMAIL RESPONSE ON 11-JAN-2024 WITH THE FOLLOWING RESPONSES INCLUDING A DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION SUCH AS ADDITIONAL ANESTHESIA OR PROLONGED HOSPITAL STAY QUESTIONS. ADDITIONALLY, THEY NOTED THE DELAY OR MEDICAL INTERVENTION PUT THE PATIENT AT RISK FOR ADVERSE EVENTS. IN RESPONSE TO THE ABOVE REPLY, PENTAX OF AMERICA, INC. SUBMITTED ANOTHER SET OF QUESTIONS AGAIN TO GATHER FURTHER INFORMATION, BUT HAVE NOT YET RECEIVED A RESPONSE. 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. CUSTOMER REPORTS IMAGE FAILURE. VIDEO GASTROSCOPE WITHOUT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798357 PENTAX VIDEO UPPER G.I.SCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10 04961333248315

    Patients

    Seq Age Sex Outcome Treatment
    1