ENDOSCOPE POSITION DETECTING UNIT
Received Aug 24, 2023 · Event occurred Aug 1, 2023
Report 3002808148-2023-08873 · MDR key 17611416
Device
Generic name
Endoscope Position Detecting Unit
Manufacturer
Shirakawa Olympus Co., Ltd.Model number
UPD-3Product problems
- Defective Component
- Defective Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THE SUBJECT DEVICE DISPLAYED ERROR CODE N907; HOWEVER; PER THE LEGAL MANUFACTURER, THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Additional Manufacturer Narrative
ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER ARE IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.
Description of Event or Problem
THE CUSTOMER REPORTED THE ENDOSCOPE POSITION DETECTING UNIT DISPLAYED ERROR CODE N907 (IMAGE PROCESSOR/LIGHT SOURCE DEFECT). THE ERROR WAS NOTICED BEFORE A DIAGNOSTIC PROCEDURE ON THE SCOPE GUIDE. THERE WAS A DELAY OF MORE THAN 15 MINUTES AND THE PROCEDURE WAS COMPLETED WITHOUT SCOPE GUIDE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.