MAUDE Adverse Event Report: AESCULAP AG AESCULAP AEOS; MICROSCOPY

Model Number	PV010
Medical Device Problem Code	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
Manufacturing site evaluation: investigation on-going.Additional information / investigation results 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
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: AESCULAP AEOS
• Common Device Name: MICROSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12079265
• Report Number: 9610612-2021-00466
• Device Sequence Number: 11681188
• Product Code: FSO
• UDI-Device Identifier: 04046955206742
• UDI-Public: 4046955206742
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• 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