MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM / ALWAYS- ON TIP TRACKED SERRATED FORCEPS

Model Number	SYS-3000 / INS-0372
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597)
Date of Event	01/23/2020
Type of Reportable Event	Death
Event or Problem Description
After the 5th forceps pass, significant bleeding occurred as blood (including clots) were backing up in patients trachea and et tube.Anesthesia proceeded with a double lumen tube to stabilize right lung bleeding while ventilating the left lung.Patient admitted to icu as of 4pm on (b)(6) 2020.Patient has a history of ascites and cirrhosis.Updated about the outcome of the case from physician on (b)(6) 2020.The patient expired at 1am on (b)(6) 2020.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM / ALWAYS- ON TIP TRACKED SERRATED FORCEPS
• Common Device Name: SPIN THORACIC NAVIGATION SYSTEM / ALWAYS- ON TIP TRACKED SERRATED FORCEPS
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• MDR Report Key: 10092166
• Report Number: 3007222345-2020-00001
• Device Sequence Number: 3122364
• Product Code: JAK
• UDI-Device Identifier: 00815686020088
• UDI-Public: 00815686020088
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: Health Professional
• Device Expiration Date: 09/16/2022
• Device Model Number: SYS-3000 / INS-0372
• Device Catalogue Number: SYS-3000 / INS-0372
• Device Lot Number: 82124160901 / 03997190904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: Death
• Patient Age: 69 YR