MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. ACCY DB-2040 NEXFRAME BILATERAL; INSTRUMENT, STEREOTAXIC

Model Number	DB-2040
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported during surgery the center multi lumen adapter cannula holes were tight.It was hard to put the cannulas down a certain hole.The surgeon rotated the adapter and used a different hole.The issue was not resolved at the time of the report.No surgical intervention occurred or was planned.The patient was alive without injury at the time of the report.
Additional Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis identified an internal lumen issue of the multi-lumen adapter.(b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACCY DB-2040 NEXFRAME BILATERAL
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 7655344
• Report Number: 3012165443-2018-00007
• Device Sequence Number: 124075
• Product Code: HAW
• UDI-Device Identifier: 00643169214811
• UDI-Public: 00643169214811
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 04/03/2019
• Device Model Number: DB-2040
• Device Catalogue Number: DB-2040
• Device Lot Number: 082509318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 07/31/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/11/2018; 08/07/2018; 10/04/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1