MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS VALLEYLAB LS10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	VLLS10GEN
Medical Device Problem Codes	Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: ls1037, ligasure atlas handswitch37cm, (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.
Event or Problem Description
It was reported that during the laparoscopic right hemicolectomy, the device initially functioned properly.It would seal with evidence of energy delivery and end tone but there was no regrasp alert.The device would cut when the jaws would not open after about one hour and was unable to be used.Despite this, the power appeared to still be reaching the device, as it continued to make the usual sounds when the energy buttons were pressed.On day two after the operation, the patient had approximately 500ml of bleeding due to difficulty of adequately sealing of transected omentum and retroperitobal tissue that was self-limiting but resulted in a prolonged ileus.The patient¿s hospitalization was extended by three days, resulting in a total hospital stay of eight days, due to a delayed return of bowel function.The procedure was completed using clips and diathermy laparoscopically.

• Brand Name: VALLEYLAB LS10
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22162806
• Report Number: 3006451981-2025-00064
• Device Sequence Number: 12931307
• Product Code: GEI
• UDI-Device Identifier: 10884521512801
• UDI-Public: 10884521512801
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• PMA/510(K) Number: K143654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: VLLS10GEN
• Device Catalogue Number: VLLS10GEN
• 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: 05/13/2025
• Initial Report FDA Received Date: 06/07/2025
• 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: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female