MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number VLFT10GEN

Device Problems Application Program Problem: Parameter Calculation Error (1449); Device Displays Incorrect Message (2591)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

According to the reporter, prior to use, the device had error code 420 - usage limit.There was no patient involvement.Medtronic's initial evaluation of the incident device found an ft10 generator software issue related to the customer's operating software version in which the authentication check gives an incorrect error message.

Manufacturer Narrative

D10 concomitant product/s: lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot #32210257x) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device data was available for evaluation.An evaluation was led of a vlft10gen for a non-reportable condition involving an error message with a ligasure device.During the investigation, a generator software issue was identified as being related to the reported error message in which this error message may occur when the vlft10gen generator performs an authentication check to confirm that the ligasure instrument has not been used previously.This identified software issue has a potential for patient harm.Software enhancements have been implemented to mitigate this condition.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALLEYLAB FT10
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19006337
• MDR Text Key: 339118128
• Report Number: 1717344-2024-00837
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: 10884521516328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• 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
• Treatment: SEE H11