MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PASSIVE BIOPSY NEEDLE KIT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733068

Device Problem Defective Device (2588)

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

Event Date 06/10/2019

Event Type  malfunction  

Event Description

The small blue screw attached to the needle would not tighten at all on the needle -- this cannot be used unless the small blue screw is able to tighten on the needle.

• Brand Name: PASSIVE BIOPSY NEEDLE KIT
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir.; louisville CO 80027
• MDR Report Key: 8703529
• MDR Text Key: 148158637
• Report Number: 8703529
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA