OR1 NEO IP, BAS

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, WE WILL SEND OUR SERVICE TECH TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING A COLONOSCOPY, THE DOCTOR HAD JUST SNARED A POLYP AND HAD BLEEDING WHEN THE WHOLE SYSTEM WENT DARK. THEY REBOOTED THE SYSTEM BUT IT TOOK SEVERAL MINUTES TO COME BACK UP, SO THEY BROUGHT IN A BACK-UP TOWER TO CONTROL BLEEDING AND FINISH THE CASE. THE DELAY WAS ABOUT 5 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

CHANGES MADE FROM THE INITIAL REPORT: SECTION B1 WAS CORRECTED FROM "ADVERSE EVENT" TO "PRODUCT PROBLEM". "OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS" WAS UNCHECKED IN SECTION B2 UPDATED THE UDI NUMBER IN SECTION D4. PER EVALUATION BY OUR SERVICE TECH CONDUCTED IN THE FIELD: THE LIFETIME FOR UPS BATTERY (B)(6), MANUFACTURER P/N:50080-23R) DECLARED BY MANUFACTURER IS 2 YEARS. THE ISSUE WAS CAUSED BY AGING UPS BATTERY WHICH EXCEEDED THE MANUFACTURER DECLARED LIFETIME AND THIS IS DEEMED TO BE NORMAL WEAR-AND-TEAR. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).