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.

Description of Event or Problem

ON 19-DEC-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL BIPOLAR HOT HEMOSTASIS FORCEPS MODEL HS-D2622S SERIAL NUMBER (B)(6) IN JAPAN. DURING ENDOSCOPIC SUBMUCOSAL DISSECTION, A BIPOLAR HEMOSTATIC FORCEPS FOR ENDOSCOPES WAS INSERTED FOR HEMOSTASIS. WHEN THE SLIDER OF THE OPERATION SECTION WAS OPERATED AT THE HEMOSTASIS SITE, THE CUP PART OF THE HEMOSTATIC FORCEPS DID NOT OPEN AND THE HEMOSTASIS OPERATION COULD NOT BE PERFORMED. WHEN THE HEMOSTATIC FORCEPS WAS REMOVED FROM THE PATIENT'S BODY AND OPENING AND CLOSING OF THE CUP PART WAS ATTEMPTED, IT OPENED AND CLOSED WITHOUT ANY PROBLEM. HOWEVER, WHEN THE HEMOSTATIC FORCEPS WAS REINSERTED, THE CUP PART DID NOT OPEN AND THE HEMOSTASIS OPERATION COULD NOT BE PERFORMED. THE PROCEDURE WAS COMPLETED USING A NEW HEMOSTATIC FORCEPS. 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.

Additional Manufacturer Narrative

G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. THE ENDOSCOPE USED IN CONJUNCTION WITH THE AFFECTED DEVICE WAS AN OLYMPUS PCF-H290TI. THE AFFECTED DEVICE IS CURRENTLY PENDING RETURN FROM THE DISTRIBUTOR FOR FURTHER EVALUATION. INVESTIGATION IS IN PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

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.