BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 22465604 · Received July 9, 2025

    Report

    Report Number
    9610877-2025-00070
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 16, 2025
    Report Date
    September 10, 2025
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    KGE
    UDI-DI
    04961333221554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. ADDITIONAL INFORMATION THE AFFECTED PRODUCT HAS NOT YET BEEN RETURNED AND IS CURRENTLY PENDING RETURN FROM THE DISTRIBUTOR. INVESTIGATION IS IN PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: B4: DATE OF THIS REPORT - UPDATED. G6: FOLLOW-UP #: 1. H2: IF FOLLOW-UP, WHAT TYPE? - UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER - "NO" TO "YES". H6: CODES UPDATED - MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. ADDITIONAL INFORMATION: D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI). H11: EVALUATION SUMMARY. EVALUATION SUMMARY: IT WAS DETERMINED THAT THE COMPLAINT PRODUCT WAS USED WITH OBLIQUE-VIEW OR SIDE-VIEW ENDOSCOPES, WHICH IS PROHIBITED IN THE IFU. WHEN PASSING THROUGH THE FORCEPS ELEVATOR AT THE DISTAL END OF THE ENDOSCOPE, DIAGONAL STRESS WAS APPLIED TO THE ENGAGEMENT PART BETWEEN THE FRAME AND SHEATH, WEAKENING THE FIXATION AND CAUSING THE FRAME TO DETACH FROM THE SHEATH. NOTE: 1. THE COMPLAINT PRODUCT WAS DISCARDED AT THE FACILITY, SO PHYSICAL INVESTIGATION WAS NOT POSSIBLE. 2. THE PRODUCT'S INSTRUCTIONS FOR USE CLEARLY STATE IN SECTION 2 OF "COMPATIBLE EQUIPMENT" THAT IT SHOULD NOT BE USED WITH OBLIQUE-VIEW OR SIDE-VIEW ENDOSCOPES. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE OR HAZARD. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE REVIEW BY DHR CONFIRMED THAT THE INSTRUMENT 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 ON 10-JUN-2022. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    ON 19-JUN-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL BIPOLAR HOT HEMOSTASIS FORCEPS MODEL HS-D2618, LOT NUMBER C223821 IN JAPAN. DURING AN ENDOSCOPIC PAPILLECTOMY, THE BIPOLAR HEMOSTATIC FORCEPS WAS USED. THE FORCEPS FUNCTIONED NORMALLY DURING THE INITIAL COAGULATION HEMOSTASIS. HOWEVER, WHEN THE CUP WAS OPENED AGAIN, THE TIP OF THE FORCEPS APPEARED TO EXTEND MORE THAN USUAL, PROMPTING REMOVAL FROM THE ENDOSCOPE FOR INSPECTION. IT WAS CONFIRMED THAT THE CUP PORTION HAD SIGNIFICANTLY PROTRUDED FROM THE SHEATH, AND THE INTERNAL WIRE WAS EXPOSED. WHEN THE HANDLE WAS OPERATED SEVERAL TIMES, THE WIRE RETRACTED INTO THE SHEATH, BUT THE CUP PROTRUDED AGAIN UPON REOPENING, LEADING TO THE DISCONTINUATION OF ITS USE FOR SAFETY REASONS. THE HEMOSTATIC PROCEDURE WAS COMPLETED USING A NEW BIPOLAR HEMOSTATIC FORCEPS. THIS EVENT OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT HARM. 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
    978723 PENTAX HEMOSTASIS FORCEPS, WD2.6, LN1800 KGE HOYA CORPORATION PENTAX TOKYO OFFICE HS-D2618 04961333221554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown