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

Model Number SYS-4000

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned for evaluation.The connector cable port was replaced on-site which corrected the reported issue.Veran will continue to monitor field performance for this device.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

Event Description

The site recently replaced their connector cable port due to it being broken.During their case they continued to receive a "vpad not connected" error message.They tried several different connector cables and were still receiving this error message.They decided not to proceed with veran.Although there was no death or serious injury, this event is being reported due to the navigated procedure being discontinued after the patient was under anesthesia.

Manufacturer Narrative

This report is being supplemented to correct b3: event date of the initial medwatch report.B3 should be (b)(6) 2023.

Manufacturer Narrative

This report is being supplemented to provide the results of the investigation of the reported issue.The connector piece that was replaced was not returned, so no further investigation of the failure mode could take place.According to the investigation, there are several potential causes for the connector piece to break in the cable port including accidental or improper handling, plugging in the wrong instrument, or physical damage to the relevant components.A definitive root cause could not be determined.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Type of Device: NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17242473
• MDR Text Key: 318265802
• Report Number: 3007222345-2023-00064
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 815686020101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other