MAUDE Adverse Event Report: SYNAPTIVE MEDICAL INC. BRIGHTMATTER GUIDE; SURGICAL NAVIGATION SYSTEM

Model Number	1.3.1
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	04/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The workflow files, logs, and patient scans for surgeries on (b)(6) 2017 were obtained and anonymized on (b)(6) 2017.The data were analyzed by a synaptive software developer.In addition, a synaptive representative went to the site to test the equipment.The hardware, software and instruments all passed specifications.The root cause is that inadequate registration was performed by the clinical staff during the procedure (against existing synaptive documentation and software controls).The surgeon also indicated that he was satisfied with the outcome of the second procedure completed using the same system.
Event or Problem Description
A site representative reported that during the procedure brightmatter guide had led the surgeon to believe that he was at the site of the tumor, so he proceeded with resection.However, post-operative pathology results indicated that the tissue was healthy brain tissue.A second procedure was then scheduled for the patient.Post-operative pathology results indicated that the tissue was grade 1 meningioma.During both procedures, anatomical landmarks were used for registration using the same system.No patient harm, or death was observed during the procedures.

• Brand Name: BRIGHTMATTER GUIDE
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): SYNAPTIVE MEDICAL INC.; 555 richmond street west; suite 800; toronto, on M5V 3 B1; CA M5V 3B1
• MDR Report Key: 6584291
• Report Number: 3012075008-2017-00001
• Device Sequence Number: 13592183
• Product Code: HAW
• UDI-Device Identifier: 00670082000078
• UDI-Public: (01)00670082000078
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K153281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 1.3.1
• Device Catalogue Number: SYN-0027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR