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

Model Number	9733068
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.No devices were returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while in a stereotactic biopsy of the left cerebral peduncular, the biopsy needle was found to be defective.It was reported that the depth stop "puck" of the unit would not engage on the needle when tightened.It was noted that the issue was discovered prior to use and that a second needle was used to complete the procedure.There was a reported delay to the procedure of fifteen minutes due to this issue.There was no reported impact on patient outcome.

• Brand Name: PASSIVE BIOPSY NEEDLE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 9403146
• Report Number: 3012165443-2019-00023
• Device Sequence Number: 2973051
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR