AESCULAP AEOS
Received Jun 28, 2021 · Event occurred Jun 7, 2021
Report 9610612-2021-00466 · MDR key 12079265
Device
Product problems
- Unexpected Shutdown
- Unexpected Shutdown
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED UPON INVESTIGATION RESULTS, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE DUE TO RISK FILE- NO MALFUNCTION OR SERIOUS INJURY.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PV010 - AESCULAP AEOS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AESCULAP AEOS SOFTWARE CRASHED AFTER BEING DRAPED AND WHEN READY TO BE PUSHED IN FOR SURGERY. AFTER MULTIPLE REBOOT ATTEMPTS AND HARD RESTARTS TO THE ENTIRE AEOS SYSTEM, THE SURGEON DECIDED TO USE THE TRADITIONAL MICROSCOPE. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THIS OCCURRED DURING THE BEGINNING OF AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE; THE PATIENT WAS UNDER ANESTHESIA AND THE INITIAL INCISION HAD BEEN MADE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).