MAUDE Adverse Event Report: FHC, INC. STARFIX; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Device Problems Fitting Problem (2183); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Event Description

During the procedure, the probe was being advanced into the starfix device and the needle holder was not fitting into the starfix device properly.After several attempts the probe was able to be placed into patient's brain.Arm was used to take a shot to confirm that the probe was too deep and past the projected point.Patient monitored post-procedure and no harm identified.

• Brand Name: STARFIX
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC, INC.; 1201 main st.; bowdoin ME 04287
• MDR Report Key: 6721287
• MDR Text Key: 80296884
• Report Number: 6721287
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES