MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MOTOR MR8 ELECTRIC NAVIGATED; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	EM800N
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Chemical Exposure (2570)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3:no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during cranial resection procedure the equipment does not show the correct anatomical point.It was reported th at bleeding occurs when using the device.There was a delay of one hour or longer and the patient was under anasthesia during the procedure.This led to extended hospitalization for the patient and the patient was taken into the intensive care unit (icu).Additional information regarding the patient impact is being followed up from the facility.
Additional Manufacturer Narrative
H3:no conclusion can be drawn.No evaluation was performed, as the device was discarded.If the device is returned in the future, product analysis may be performed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MOTOR MR8 ELECTRIC NAVIGATED
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21068868
• Report Number: 1625507-2025-00003
• Device Sequence Number: 3277608
• Product Code: HBF
• UDI-Device Identifier: 00763000430924
• UDI-Public: 00763000430924
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K183644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EM800N
• Device Catalogue Number: EM800N
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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: Hospitalization
• Patient Sex: Female