PENTAX

Additional Manufacturer Narrative

THE REPORTED EVENT WAS THAT A LOUD POPPING SOUND WAS HEARD FROM THE PROCESSOR AND SPARKS WERE OBSERVED FROM THE SIDE OF THE UNIT. THE PROCESSOR WAS REPLACED WITH AN ALTERNATIVE UNIT. THE EVENT DID NOT OCCUR DURING AN ENDOSCOPIC PROCEDURE, AND NO PATIENT HARM OR PROCEDURE DELAY WAS REPORTED. PENTAX MEDICAL AMERICA PERFORMED GFE TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT AND RECEIVED RESPONSES TO ITS INQUIRIES VIA EMAIL ON 21-APR-2026. THE PROCESSOR INVOLVED IN THE EVENT WAS OPERATING WITH SOFTWARE VERSION 0107C-1.0061. THE AVAILABILITY OF THE DEVICE FOR EVALUATION IS CURRENTLY UNKNOWN. 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 17-APR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN NORTH CAROLINA, UNITED STATES. A LOUD POPPING SOUND WAS HEARD FROM THE PROCESSOR IN THE ENDOSCOPY ROOM, AND SPARKS WERE REPORTED TO HAVE SHOT OUT FROM THE SIDE OF THE PROCESSOR. THE PROCESSOR IN QUESTION WAS REPLACED WITH AN ALTERNATIVE PROCESSOR. THIS EVENT DID NOT OCCUR DURING AN ENDOSCOPIC PROCEDURE. THERE WAS NO PATIENT HARM OR PROCEDURE DELAY RESULTING FROM THIS MALFUNCTION. 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

CORRECTION INFORMATION: B4: DATE OF THIS REPORT - UPDATED. 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-UPDATED. ADDITIONAL INFORMATION: D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI). H4: DEVICE MANUFACTURE DATE. H11: EVALUATION SUMMARY. EVALUATION SUMMARY: THE REPORTED EVENT WAS THAT A LOUD POPPING NOISE WAS HEARD AND SPARKS WERE OBSERVED COMING FROM THE SIDE OF THE DEVICE. NO ADDITIONAL PATIENT HARM HAS BEEN REPORTED TO DATE. BASED ON THE INVESTIGATION, POTENTIAL ROOT CAUSES OF THIS FAILURE INCLUDE FAILURE OF EITHER THE LAMP CARTRIDGE INSTALLED INSIDE THE ENCLOSURE OR A CAPACITOR ON THE CIRCUIT BOARD. THE EXACT FAILED COMPONENT COULD NOT BE DETERMINED. A GOOD FAITH EFFORT (GFE) WAS PERFORMED TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO MEANINGFUL RESPONSE WAS RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THAT THE PROCESSOR WAS MANUFACTURED UNDER NORMAL CONDITIONS ON 21-JUL-2025, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS, AND THE ACTUAL DATE SHIPPED WAS CONFIRMED AS 18-AUG-2025. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.