PENTAX

Additional Manufacturer Narrative

CORRECTION INFORMATION B4: DATE OF THIS REPORT G1: CONTACT OFFICE - UPDATED G6: FOLLOW UP #1 H2: IF FOLLOW-UP, WHAT TYPE? EVALUATION SUMMARY: ON 09-FEB-2026, IT WAS DETERMINED THAT THE PRODUCT CONCERNED IS AN OEM PRODUCT AND IS NOT A MEDICAL DEVICE DESIGNED, MANUFACTURED, OR QUALITY-CONTROLLED BY PENTAX MEDICAL. ACCORDINGLY, THE CASE WAS RE-EVALUATED. BASED ON THE RE-EVALUATION, THIS EVENT DOES NOT INVOLVE A DEVICE MALFUNCTION ATTRIBUTABLE TO PENTAX MEDICAL AS THE MANUFACTURER. NO PATIENT HARM HAS BEEN REPORTED. BASED ON THE ABOVE, THIS EVENT DOES NOT MEET THE CRITERIA FOR MDR SUBMISSION BY PENTAX MEDICAL. THEREFORE, NO FURTHER REPORTING IS REQUIRED.

Additional Manufacturer Narrative

G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. WE ARE CURRENTLY IN CONTACT WITH OUR DISTRIBUTOR TO DETERMINE WHETHER THE DEVICE CAN BE RETURNED. INVESTIGATION IS IN PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

Description of Event or Problem

ON 20-NOV-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL BIPOLAR HOT HEMOSTASIS FORCEPS MODEL HS-D2622W LOT NUMBER 2025020501HF IN JAPAN. WITH THE BIPOLAR HEMOSTATIC FORCEPS FOR ENDOSCOPES, COMPLETE HEMOSTASIS BY CAUTERIZATION COULD NOT BE ACHIEVED. WHEN THE HEMOSTATIC FORCEPS WAS ENERGIZED AGAINST THE BLEEDING, THE HEMOSTATIC EFFECT OF CAUTERIZATION WAS INCONSISTENT AND AREAS WHERE HEMOSTASIS WAS ACHIEVED AND AREAS WHERE HEMOSTASIS WAS NOT ACHIEVED WERE CONFIRMED. THE TREATMENT WAS COMPLETED USING A HEMOSTATIC FORCEPS FROM ANOTHER COMPANY. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT OCCURRED 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.