MAUDE Adverse Event Report: NEOCIS INC. NEOCIS GUIDANCE SYSTEM; YOMI

Model Number	DRW-1000-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.The adverse event was related to the patient's condition and reaction to anesthesia, not the use of the device.With review of available information, there are no indications of a malfunction of the device or failure to meet specifications.The user selected to remove the yomilink bone during the emergency.The patient was transported to the hospital and stabilized.
Event or Problem Description
It was reported that prior to the robotic procedure and following administration of anesthesia, the patient's heart rate dropped.The user removed the yomilink bone quickly and called emergency services.The patient was taken to the hospital and stabilized.No further injuries or medical intervention were reported as a result of this event.

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Common Device Name: YOMI
• Manufacturer (Section D): NEOCIS INC.; 545 nw 26th st; unit 700; miami 33127
• Manufacturer (Section G): NEOCIS INC.; 545 nw 26th st; unit 700; miami FL 33127
• Manufacturer Contact: jorge fernandes ; 545 nw 26th st; unit 700; miami, FL 33127
• MDR Report Key: 23094726
• Report Number: 3012787974-2025-80097
• Device Sequence Number: 13098171
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 810004900004
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: DRW-1000-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Other
• Patient Sex: Unknown