MAUDE Adverse Event Report: FHC, INC, MICROTARGETING MICROTABLE - SINGLE; STEREOTAXIC INSTRUMENT

Model Number	66-MT-D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report was originally submitted on 06/24/2019 but due to a technical error, it did not upload.
Event or Problem Description
Fhc received information regarding an event relating to the fhc microtable, model # 66-mt-d1, sn# (b)(4).The patient suffered a hemorrhage and stroke.Physician noted that this was not the result of an issue with the microtable.The microtable was created and sterilized according to the plan from the ct scans.The case went well and uneventful with no injury or concern of injury to the patient.There were 4 biopsies prepared as specimen for pathology.There were at least 6 passes with the brain lab biopsy needle performed.There was no significant blood loss during the procedure.The patient was awakened from anesthesia and extubated.The patient was then moved to recovery.Recovery room nurse later called the physician indicating that the patient was not waking up.The patient was extubated, breathing on her own and stable.As of the date of this report, the patient was in stable condition the morning of (b)(6) 2019.

• Brand Name: MICROTARGETING MICROTABLE - SINGLE
• Common Device Name: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC, INC,; 1201 main street; bowdoin ME 04287
• MDR Report Key: 8939253
• Report Number: 3002250546-2019-00005
• Device Sequence Number: 10819537
• Product Code: HAW
• UDI-Device Identifier: 00873263006436
• UDI-Public: 00873263006436
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K132611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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: 66-MT-D1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 08/28/2019
• 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: Hospitalization