MAUDE Adverse Event Report: FHC, INC, MICROTARGETING DRIVE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT - HAW

Model Number FC1006

Device Problems Device Issue (2379); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a reusable device that is cleaned and sterilized after each use.During cleaning and sterilization process, it is believed the screw was lost.This was not noticed until the surgery was in process.The surgery therefore had to be aborted.

Event Description

Product: microtargeting drive system.A case had to be aborted today in (b)(6) as a screw went missing (maybe during sterilization process) out of the microtargeting drive kit.

• Brand Name: MICROTARGETING DRIVE SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT - HAW
• Manufacturer (Section D): FHC, INC,; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC,; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: craig pagan ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 6390824
• MDR Text Key: 69520758
• Report Number: 3002250546-2017-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K011992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FC1006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1