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); No Apparent Adverse Event (3189)

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

Event Date 10/22/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: lf4418, open sealer lf4418 curved large jaw (lot#31790284x) 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 in vestigation 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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to use, the device was not recognized by the generator as it display an error code 420 "device has already been used".Another similar device was plugged into different generator encountering the same code.A 3rd device was pulled with the same lot number and it worked fine.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.

• 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: 18594839
• MDR Text Key: 333959869
• Report Number: 1717344-2024-00250
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521548350
• UDI-Public: 10884521548350
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 H10