MAUDE Adverse Event Report: FHC WAYPOINT STEREOTACTIC PLATFORM; STEREOTACTIC INSTRUMENT

Model Number	MP-KIT-P-BI
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Incident occurred on (b)(6) 2021, during a bilateral platform case using fhc waypoint stereotactic platform (mp-kit-p-bi).While fitting the platform to the patient, it did not fit.The case had to be cancelled and rescheduled for (b)(6) 2021.After the case was canceled, new scans were complete and the platform was rebuilt using the new scans.The follow up case was completed on (b)(6) 2021 successfully.
Additional Manufacturer Narrative
Fhc is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by fhc, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Fhc has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, fhc, or its employees that the device, fhc or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Fhc objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
Incident occurred on (b)(6) 2021, during a bilateral platform case using fhc waypoint stereotactic platform (mp-kit-p-bi).While fitting the platform to the patient, it did not fit.The case had to be cancelled and rescheduled for (b)(6) 2021.After the case was canceled, new scans were complete and the platform was rebuilt using the new scans.The follow up case was completed on (b)(6) 2021 successfully.

• Brand Name: WAYPOINT STEREOTACTIC PLATFORM
• Common Device Name: STEREOTACTIC INSTRUMENT
• Manufacturer (Section D): FHC; 1201 main street; bowdoin ME 04287
• MDR Report Key: 12089004
• Report Number: 3002250546-2021-00001
• Device Sequence Number: 1622334
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 06/29/2021

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-BI
• Device Catalogue Number: MP-KIT-P-BI
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1