MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC BIOPSY NEEDLE; INSTRUMENT, STEREOTAXIC

Model Number 9733068

Device Problem Output Problem (3005)

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

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.The biopsy needle kit was returned to the manufacturer for evaluation.Testing found that the depth stop on the needle was not drilled through the set screw.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cranial biopsy procedure.It was reported that the screw on the adjustable depth collar would not tighten.The biopsy needle was replaced and the issue was resolved.There was no reported delay and no reported impact to patient outcome.

• Brand Name: BIOPSY NEEDLE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer (Section G): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9716598
• MDR Text Key: 179620317
• Report Number: 3012165443-2020-00004
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K971247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2021
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066513519C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1