MAUDE Adverse Event Report: AESCULAP AG AESCULAP AEOS; MICROSCOPY

Model Number	PV010
Medical Device Problem Codes	Operating System Becomes Nonfunctional (2996); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, they will be provided in a supplemental report.
Event or Problem Description
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).
Additional Manufacturer Narrative
D4- updated lot number investigation: investigation was carried out by r&d department based on the information provided.The following steps have been provided to eliminate the root cause of the failure described: -problem with epu (operating system) - replace epu, wrong sw version 2.6 -installation of new epu with sw 2.7 -perform calibration -update keyboard fw -send debugcollectorfiles with roboter-data.Pictorial documentation device not provided, therefore no pictorial documentation possible.Batch history review the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Four complaints against this serial number have been received up to now.Explanation and rationale due to the current deviation, the root cause of the problem is related to a software error.Conclusion and root cause due to the current deviation and according to explanation and rationale, the root cause of the problem is most probably software-related.Corrective action a capa has been opened.
Event or Problem Description
No updates.

• Brand Name: AESCULAP AEOS
• Common Device Name: MICROSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12076969
• Report Number: 2916714-2021-00123
• Device Sequence Number: 3674868
• Product Code: FSO
• UDI-Device Identifier: 04046955206742
• UDI-Public: 4046955206742
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021
• Report Date (Section F): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PV010
• Device Catalogue Number: PV010
• Device Lot Number: 52596370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 06/28/2021