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

Model Number	MP-KIT-P-ED-00598
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Physician stated that he had a safety concern regarding the fhc multi oblique dual trajectory platform targeting guides: "in our or the other day, despite having done many of these cases, the wrong number was read-out (biopsy depth rather than target depth), resulting in a placement that was 1cm too deep.Fortunately, no injury resulted (the tip was in a csf space), but there was the real possibility of disaster.I would recommend that you either 1) remove the biopsy depth column and simply note separately that biopsy depth is 10mm further (something that should be obvious to anyone, anyway), or else 2) simply write in that column "+10mm".This issue was due to user error, the depth sheet was correct and displayed as it was intended to.

• Brand Name: FHC WAYPOINT STEREOTACTIC SYSTEM
• Common Device Name: STEREOTACTIC INSTRUMENT
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• MDR Report Key: 10756146
• Report Number: 3002250546-2020-00005
• Device Sequence Number: 19704582
• Product Code: HAW
• UDI-Device Identifier: 00873263005989
• UDI-Public: 00873263005989
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 10/28/2020

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-ED-00598
• Device Catalogue Number: MP-KIT-P-ED
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1