POWER LED RUBINA, OPAL1 NIR/ICG
Received Sep 17, 2024 · Event occurred Aug 23, 2024
Report 9610617-2024-00315 · MDR key 20238127
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Unexpected Shutdown
- Adverse Event Without Identified Device or Use Problem
- Unexpected Shutdown
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "THE DEVICE SWITCHES OFF COMPLETELY DURING USE." NO FURTHER INFORMATION AND NO NEGATIVE IMPACT IN STATE OF HEALTH WAS REPORTED.
Description of Event or Problem
IT WAS CONFIRMED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A PROLONGATION OF LESS THAN 15 MINUTES. IT WAS ALSO CONFIRMED THAT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS PROVIDED IN SECTION B3 AND B5. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
DEVICE EVALUATION: DURING THE INVESTIGATION OF THE RETURNED TL400 POWER LED RUBINA LIGHT SOURCE NO OPTICAL DEFECT ON THE OUTSIDE AND INSIDE COULD BE FOUND. ALSO, NO OTHER ERROR COULD BE DETECTED DURING INSPECTION. ENTRIES FOR EVENTS 400 OR 404 WERE PRESENT IN THE LOG FILE, HOWEVER, THESE COULD NOT BE GENERATED DURING THE TEST/ENDURANCE TEST WITH MAXIMUM PERFORMANCE SETTINGS. THE ERROR ENTRIES ARE NOT REPRODUCIBLE. A SOFTWARE RUNTIME ERROR ON INSTALLATION AT CUSTOMER SITE IS CONCLUDED AS THE MOST PROBABLE ROOT CAUSE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).