PENTAX

Additional Manufacturer Narrative

G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. H6: CONTINUED: HEALTH EFFECT - CLINICAL CODE: 2867 FOREIGN BODY IN PATIENT. HEALTH EFFECT - IMPACT CODE: 4641 UNEXPECTED MEDICAL INTERVENTION. MEDICAL DEVICE PROBLEM CODE: 1562 MATERIAL SEPARATION. COMPONENT CODE: 432 SEAL. TYPE OF INVESTIGATION: 4118 TYPE OF INVESTIGATION NOT YET DETERMINED. INVESTIGATION FINDINGS: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 CONCLUSION NOT YET AVAILABLE. _________________________ THE REPORTED EVENT WAS DETACHMENT OF A PORTION OF THE SINGLE-USE INSTRUMENT CHANNEL INLET SEAL (OF-B215) DURING A COLONOSCOPY PROCEDURE. THE DETACHED FRAGMENT WAS RETRIEVED FROM THE PATIENT, AND NO PATIENT HARM WAS REPORTED. PENTAX MEDICAL EMEA PERFORMED A GOOD FAITH EFFORT TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT AND RECEIVED RESPONSES TO ITS INQUIRIES VIA EMAIL ON (B)(6) 2026. ACCORDING TO INFORMATION RECEIVED FROM THE DISTRIBUTOR, THE BIOPSY FORCEPS WERE INSERTED THROUGH THE INLET SEAL CAP ONLY ONCE. THE BIOPSY FORCEPS USED IN THIS CASE WERE IDENTIFIED AS A VEDKANG BIOPSY FORCEPS, MODEL VDK-FB-23-230-O-P1-B1, LOT NO. 2025052103VFB. THE COLLECTED FRAGMENT AND UNUSED OF-B215 PRODUCTS FROM THE SAME LOT ARE BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. ACCORDING TO THE IFU, ONLY DEVICES WITH A DIAMETER OF 2.4 MM OR LESS MAY BE INSERTED THROUGH THE INLET SEAL CAP WHILE THE CAP IS CLOSED. THE COMPATIBILITY OF THE BIOPSY FORCEPS USED IN THIS CASE WITH THE IFU REQUIREMENTS IS BEING EVALUATED AS PART OF THE ONGOING INVESTIGATION. 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 (B)(6) 2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL SINGLE USE INLET SEAL MODEL OF-B215, LOT NUMBER 0062051 IN IRELAND WITHIN THE (B)(6) REGION. DURING COLONOSCOPY PROCEDURE, WHEN THE BIOPSY FORCEPS WAS INSERTED THROUGH THE SINGLE-USE INSTRUMENT CHANNEL INLET SEAL, A PART OF THE INSTRUMENT CHANNEL INLET SEAL BROKE AND FELL INSIDE THE PATIENT'S BODY. THE MEDICAL STAFF REPORTED THAT THE TIP OF THE BIOPSY FORCEPS WAS CLOSED. THE FRAGMENT OF THE INSTRUMENT CHANNEL INLET SEAL THAT FELL OFF WAS REMOVED FROM THE PATIENT'S BODY, AND THERE WAS NO 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.