NDI PASSIVE SPHERES
Received May 28, 2025 · Event occurred Apr 8, 2025
Report 3002743211-2025-00001 · MDR key 22095203
Device
Generic name
Ndi Passive Spheres
Manufacturer
Northern Digital Inc.(ndi)Model number
8800738Catalog number
8800738
Lot number
2409601
Product problems
- Failure to Sense
- Failure to Sense
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INITIAL REPORT: ON APRIL 08, 2025, NDI'S SPHERE DISTRIBUTOR, AMPLITUDE, RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL IN FRANCE, ALLEGING THAT NDI'S SENSORS (SPHERES) RETURNED A STROBE-LIKE IMAGE TO THEIR TRACKING SYSTEM, THEREBY MAKING IT IMPOSSIBLE TO VALIDATE THE VARIOUS NAVIGATION PHASES. DUE TO THIS ISSUE, THE SURGICAL TEAM DETERMINED THAT IT WAS IMPOSSIBLE TO PROGRESS THROUGH THE VARIOUS OPERATING STAGES OF THE PLANNED SURGERY. THIS RESULTED IN A 35 MINUTE DELAY IN THE SURGERY. THE SURGICAL TEAM WAS ABLE TO RESOLVE THE ISSUE BY USING SENSORS FROM ANOTHER COMPANY. IT WAS REPORTED THAT THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME.
Additional Manufacturer Narrative
NDI WILL COMPLETE A FOLLOW-UP REPORT AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.