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

Model Number DB-2040

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 7655344
• MDR Text Key: 113000016
• Report Number: 3012165443-2018-00007
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169214811
• UDI-Public: 00643169214811
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1