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

Model Number	MP-KIT-P-BI
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
After dbs bilateral lead placement surgery using starfix bilateral platform, it was noted that the post op ct revealed that on the left side the lead was placed appropriately, however the right side revealed in post op scans that the lead was 2.8 cm deeper than expected.This did not cause a delay in dbs surgery, when the lead was placed.No harm to the patient was caused during the surgery.A revision surgery was completed the following day and released.
Additional Manufacturer Narrative
Highly probable root cause: (user error) the lead slipped in the depth stop because the depth stop was not tightened when the lead was inserted the second time.

• Brand Name: WAYPOINT STEREOTACTIC PLATFORM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: kelly moeykens ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 12821534
• Report Number: 3002250546-2021-00004
• Device Sequence Number: 19993288
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: MP-KIT-P-BI
• Device Catalogue Number: MP-KIT-P-BI
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown