MAUDE Adverse Event Report: AESCULAP AG AESCULAP AEOS; DIGITAL SURGICAL MICROSCOPE

Model Number	PV010
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a aesculap aeos (part # pv010) was being setup for product display.According to the complainant, the aeos unit was setup in a hotel conference center to display to local surgeons.Reportedly, during setup two (2) hardware issues were observed: the wheel of the system was broken; right hand control was loose.No patient involvement.Although requested, additional information has not been made available.The malfunction is filed under aag reference xc (b)(4).Associated medwatch-reports: 9610612-2021-00275 ((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: DIGITAL SURGICAL MICROSCOPE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11628140
• Report Number: 9610612-2021-00276
• Device Sequence Number: 16899303
• Product Code: FSO
• UDI-Device Identifier: 04046955206742
• UDI-Public: 4046955206742
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1