MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM

Model Number SYS-4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Apnea (1720)

Event Date 09/22/2020

Event Type  Injury  

Event Description

The patient was a (b)(6) male with no known pre-existing conditions.At the time of the incident, no instruments of veran were being used.Prior to incident, physician had made roughly 3 passes to get to the rul nodule.Due to patient movement and coughing, physician took out the forceps from scope and tried to wait for patient to relax.A few minutes later, the patient stopped breathing, the medical team attended to the patient, and the case was aborted.The patient stayed overnight and no issues were seen after being admitted to the hospital for monitoring.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Type of Device: SPIN THORACIC NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: christine hardin ; 1908 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 10697857
• MDR Text Key: 211912781
• Report Number: 3007222345-2020-00011
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2020

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
• Device Operator: Health Professional
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Device Lot Number: 82546170405
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR