MAUDE Adverse Event Report: FHC, INC. WAYPOINT STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	MP-KIT-P-EO
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While using a mp-kit-p-eo (multioblique (pmt) waypoint stereotactic system, physician found the platform was labeled with the incorrect depth numbers.There was no harm to patient as physician identified the issue and proceeded accordingly.

• Brand Name: WAYPOINT STEREOTACTIC SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• MDR Report Key: 12160501
• Report Number: 3002250546-2021-00002
• Device Sequence Number: 11690682
• Product Code: HAW
• UDI-Device Identifier: 00873263005965
• UDI-Public: 00873263005965
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: MP-KIT-P-EO
• Device Catalogue Number: MP-KIT-P-EO
• Device Lot Number: 300185
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1