MalfunctionOCV
CONNECTING ARM
Received Apr 11, 2026
Report 3002808148-2026-10874 · MDR key 24852634
Device
Product problems
- Loss of or Failure to Bond
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. IN ADDITION, THE INVESTIGATION FOUND THAT THE ARM COVER ADHESIVE PART WAS MISSING. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE ADDITIONAL REPORTED FAILURE(S) DID NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE EVALUATION, THE CONNECTING ARM EXHIBITED THAT THE ARM COVER ADHESIVE PART WAS MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.