MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) KINEVO 900; MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	900
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device itself as well as the logfiles were evaluated and there is no indication that there was a malfunction of the opmi kinevo 900 that could have contributed to the focusing problems and complications during surgery.There seems to be no indication that reasonably suggests that the device has caused or contributed to the patient's death or that a malfunction of the device may have caused or contributed to this incident.
Event or Problem Description
A health care professional (hcp) reported that the opmi kinevo 900 stopped focusing during a brain operation after bleeding of the brain had started.It was further reported, that the patient lost 7 liters of blood.The device was working without any issues upon inspection; no further reported issues after the incident.The surgeon noted that the bleeding occurred before the assumed issue with the focus.The hemorrhage was under control before the loss of focus and restart of the device.No harm was reported directly from the incident.The device problem was resolved by shutting down and restarting the microscope.The patient died three days after surgery.The reason for the death remains unknown to date.

• Brand Name: KINEVO 900
• Common Device Name: MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 22795061
• Report Number: 9615010-2025-00018
• Device Sequence Number: 15532507
• Product Code: FSO
• UDI-Device Identifier: 04049539066404
• UDI-Public: (01)04049539066404(11)230810
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 900
• Device Catalogue Number: 000000-2216-914
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown