MalfunctionFBO
OES CHOLEDOCHO FIBERSCOPE
Received Dec 20, 2019 · Event occurred Nov 19, 2019
Report 8010047-2019-04498 · MDR key 9502437
Device
Product problems
- No Display/Image
- No Display/Image
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE DISAPPEARED DURING AN UNSPECIFIED OPERATION OF THE BILIARY TRACT. THE USER REPLACED THE SUBJECT DEVICE TO ANOTHER UNSPECIFIED DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT INJURY OTHER THAN REPLACING THE DEVICE.