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

Model Number	VLFT10GEN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, post operatively, after 24 hours, the patient had bleeding observed directly from the device seal.The surgeon stated the seals seemed to take longer than usual to get the end tone.He didn't feel the tissue was especially thick and it was still taking longer to seal an artery.The patient lost over 1 liter of blood and was taken back to surgery.The surgeon could see a small arterial bleed along the diaphragm that appeared to have been previously sealed that was open and bleeding.The patient was not on any medications.The device was connected to a generator with software version 5.0 at the time of the event.
Additional Manufacturer Narrative
D10 concomitant product: lf1937, jaw lap lf1937 ligasure maryland 37 cm (lot #: unknown).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.
Additional Manufacturer Narrative
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
According to the reporter, post operatively, the procedure was hiatal hernia and after 24 hours the patient had bleeding observed directly from the device seal and only this one re-opened.The surgeon stated the seals seemed to take longer than usual to get the end tone.There was no regrasp alarm.The surgeon received a ¿seal is complete¿ audible tone.He didn't feel the tissue was especially thick and it was still taking longer to seal an artery.The patient lost over 1 liter of blood and was taken back to surgery.The patient had blood transfusion necessary.The surgeon could see a small arterial bleed along the diaphragm that appeared to have been previously sealed that was open and bleeding.The patient was not on any medications.The device was connected to a generator with software version 5.0 at the time of the event.The patient was not on chemotherapy.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 21525732
• Report Number: 1717344-2025-00340
• Device Sequence Number: 21260875
• Product Code: GEI
• UDI-Device Identifier: 10884521548350
• UDI-Public: 10884521548350
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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?: No
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/11/2025
• 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: PLEASE SEE NOTE ON H11.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female