IMAGE MANAGEMENT HUB
Received Aug 25, 2019 · Event occurred Aug 1, 2019
Report 8010047-2019-03032 · MDR key 8928979
Device
Product problems
- Overheating of Device
- Overheating of Device
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC FOUND THAT THE CIRCUIT BOARD NEAR THE MAINTENANCE MONITOR TERMINAL WAS BURNT. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC SENT THE CIRCUIT BOARD NEAR THE MAINTENANCE MONITOR TERMINAL OF THE SUBJECT DEVICE TO THE SUPPLY UNIT MANUFACTURER TO IDENTIFY THE ROOT CAUSE. THE SUPPLY UNIT MANUFACTURER INVESTIGATED THE CIRCUIT BOARD. AS A RESULT, OMSC WAS REPORTED AS FOLLOWS. THE ROOT CAUSE OF THE EVENT COULD NOT BE IDENTIFIED. IT WAS ASSUMED THAT THIS EVENT WAS CONTRIBUTED TO A RANDOM FAILURE OF CAPACITOR ON THE SUBJECT CIRCUIT BOARD.
Additional Manufacturer Narrative
THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC FOUND THAT THE CIRCUIT BOARD NEAR THE MAINTENANCE MONITOR TERMINAL WAS BURNT. THIS REPORT IS AN INTERIM REPORT. THE EXACT CAUSE HAS BEEN UNDER DETAILED INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.
Description of Event or Problem
DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE SUBJECT DEVICE WAS TURNED OFF. THE POWER BUTTON INDICATOR LIT GREEN BY TURNING ON AND OFF REPEATEDLY, BUT THE SUBJECT DEVICE DID NOT START UP. THE SPARKS AND THE SMOKE CAME OUT FROM THE LEFT SIDE OF THE SUBJECT DEVICE. THE USER FELT A BURNT SMELL. ON AUGUST 2, IT WAS REPORTED THAT THESE PHENOMENA WERE NOT REPRODUCED. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING SPARKS AND SMOKE FROM THE SUBJECT DEVICE.