PENTAX

Additional Manufacturer Narrative

H4: DEVICE MANUFACTURE DATE IS UNKNOWN. CORRECTION INFORMATION. B4: DATE OF THIS REPORT - UPDATED. G1: CONTACT OFFICE - UPDATED. G6: FOLLOW-UP #: 1. H2: IF FOLLOW-UP, WHAT TYPE? - UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER - "NO" TO "YES". H6: CODES UPDATED - COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS-UPDATED. ADDITIONAL INFORMATION D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI). H4: DEVICE MANUFACTURE DATE. H11: EVALUATION SUMMARY. EVALUATION SUMMARY THE REPORTED EVENT WAS THAT THE HEMOSTAD DID NOT COAGULATE. BASED ON THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS FAILURE WAS THAT BLOOD OR OTHER SUBSTANCES ADHERED TO THE TIP OF THE DEVICE PRIOR TO THE INCIDENT AND WERE NOT PROPERLY REMOVED, THEREBY OBSTRUCTING ELECTRICAL CONDUCTIVITY AT THE TIP. NO PATIENT HARM WAS REPORTED IN ASSOCIATION WITH THIS EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THAT THE DEVICE WAS COMPLETED UNDER NORMAL CONDITIONS ON 07-OCT-2025, 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 08-OCT-2025. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE OR HAZARD. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED BY PENTAX MEDICAL NETHERLANDS. 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 11-NOV-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL BIPOLAR HOT HEMOSTASIS FORCEPS MODEL HS-D2622 SERIAL NUMBER (B)(6) IN THE NETHERLANDS WITHIN THE EMEA REGION. WHEN THE BIPOLAR HEMOSTASIS FORCEPS WAS USED DURING AN ENDOSCOPIC PROCEDURE, A SHORT CIRCUIT OCCURRED AND HEMOSTASIS BY COAGULATION COULD NOT BE ACHIEVED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE TREATMENT DEVICE. 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.