MAUDE Adverse Event Report: COVIDIEN VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VLFT10GEN
Medical Device Problem Codes	Energy Output Problem (1431); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: lf5637, ligasure lf5637 retractable l hook (lot #: 50360361x).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.
Event or Problem Description
It was reported that during a laparoscopic median arcuate ligament release, error code e402 was generated immediately during routine activation while transecting the ligament.Reactivation was necessary, sometimes multiple regrasp alarm or alert occurred.There were issues with energy activation and sealing, including inadequate or partial sealing despite evidence of energy delivery and end tones being heard.Bleeding was observed after cutting, even though the seal showed evidence of energy delivery.The tissue involved was a normal ligament bundle and the jaws were cleaned several times during the procedure.
Event or Problem Description
It was reported that during a laparoscopic median arcuate ligament release, error code e402 was generated immediately during routine activation while transecting the ligament.Reactivation was necessary, sometimes multiple regrasp alarm or alert occurred.There were issues with energy activation and sealing, including inadequate or partial sealing despite evidence of energy delivery and end tones being heard.Bleeding of 250 ml was observed after cutting, even though the seal showed evidence of energy delivery.The tissue involved was a normal ligament bundle, and the jaws were cleaned several times during the procedure.Procedure was completed using sonicision.Blood transfusion was necessary due to bleeding.
Additional Manufacturer Narrative
Additional information: a2 (date of birth), b1, b2, b5, d3 (mfr name and street 1), g3, h1.New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22393371
• Report Number: 1717344-2025-00862
• Device Sequence Number: 9401248
• Product Code: GEI
• UDI-Device Identifier: 10884521548350
• UDI-Public: 10884521548350
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 21 YR
• Patient Sex: Female