Model Number 8000-010-003 |
Device Problems
Incorrect Measurement (1383); Device Displays Incorrect Message (2591)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/22/2023 |
Event Type
malfunction
|
Event Description
|
Per the customer there was a lag in the video during a procedure which could cause an inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
|
|
Manufacturer Narrative
|
Correction: follow-up report submitted to document the device was not available for evaluation.Correction: update device code.Log files not submitted by customer for evaluation.
|
|
Event Description
|
Per the customer there was a lag in the video during a procedure which could cause an inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
|
|
Search Alerts/Recalls
|