PENTAX

Additional Manufacturer Narrative

G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. IT IS CURRENTLY UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION. 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 24-JUL-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL PORTABLE INTUBATION FIBER SCOPE MODEL FI-16RBS, SERIAL NUMBER (B)(6) IN CHINA WITHIN THE APAC REGION. DURING THE ENDOSCOPIC PROCEDURE, THE ENDOSCOPIC IMAGE BECAME UNCLEAR. THE PHYSICIAN ATTEMPTED TO ADJUST THE FOCUS, OPERATE THE ANGULATION KNOB, AND CHANGE THE INSERTION POSITION, BUT THE IMAGE DID NOT IMPROVE. THE ENDOSCOPE CONCERNED COULD NOT BE USED FOR THE PROCEDURE. AFTER REPLACING IT WITH AN ALTERNATIVE ENDOSCOPE, A CLEAR IMAGE WAS OBTAINED, AND THE PROCEDURE WAS COMPLETED. DUE TO THIS ISSUE, THE PROCEDURE WAS TEMPORARILY INTERRUPTED AND THE EXAMINATION TIME WAS EXTENDED, BUT NO PATIENT HARM OCCURRED. 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

CORRECTION INFORMATION: B4: DATE OF THIS REPORT - UPDATED. D8: WAS THIS DEVICE EVER SERVICED BY A THIRD PARTY? - "UNKNOWN" TO "YES". G6: FOLLOW-UP #: 1. H2: IF FOLLOW-UP, WHAT TYPE? - UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER - "NO" TO "YES". H6: CODES UPDATED - TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. ADDITIONAL INFORMATION: D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI). H4: DEVICE MANUFACTURE DATE. H11: EVALUATION SUMMARY. EVALUATION SUMMARY: THE REPORTED EVENT WAS A BLURRY IMAGE. A PENTAX MEDICAL ENGINEER CONSULTED WITH HOSPITAL STAFF AND IDENTIFIED THE MALFUNCTION DURING USE. NO HARM WAS CAUSED TO THE PATIENT, AND THE EXAMINATION WAS COMPLETED USING A BACKUP DEVICE. BASED ON THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS FAILURE WAS THAT THE LIGHT GUIDE FIBER AND IMAGE GUIDE FIBER WERE FRACTURED, WHICH MIGHT HAVE BEEN CAUSED BY WATER INGRESS OR LONG-TERM EXTERNAL FORCE SUCH AS COMPRESSION OR OVERBENDING OF THE IFT DURING USE OR REPROCESSING. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. INVESTIGATION COMPLETION AND RETURN DATE: 22-SEP-2025. 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 DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED AT PENTAX MEDICAL MIYAGI ON 28-AUG-2019 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 30-AUG-2019. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.