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

Model Number	VLLS10GEN
Medical Device Problem Codes	Energy Output Problem (1431); Connection Problem (2900)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Hypoglycemic Shock (4575)
Date of Event	05/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: lf1944, jaw lap lf1944 ligasure maryland 44 cm (lot#: 40450250x).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 six (6) hours after gastric sleeve / sasi (single anastomosis sleeve ileal bypass) procedure, the patient had 2 pints of blood transfusion due to hypovolemic shock caused by 1500ml endoscopic bleeding.A reoperation was performed to detect the bleeding source and stop the bleeding.The event reportedly extended hospitalization for an unknown duration.It was noted that during a procedure, the device had inadequate or partial despite evidence of energy delivery and end tones being heard.The seal reportedly showed evidence of energy delivery but bled at gastro-diaphragmatic vessels, back of the left pillars after cutting, and the sealing time of the vessel was observed to be short.It was noted that the jaws were cleaned approximately four times during the procedure.
Event or Problem Description
It was reported that six (6) hours after gastric sleeve / sasi (single anastomosis sleeve ileal bypass) procedure, the patient had 2 pints of blood transfusion due to hypovolemic shock caused by 1500ml endoscopic bleeding.A reoperation was performed to detect the bleeding source and stop the bleeding.No massive transfusion protocol (mtp) was initiated.The event reportedly extended hospitalization for an unknown duration and was admitted to semi-intensive care unit.It was noted that during a procedure, the device had inadequate or partial evidence of energy delivery and end tones being heard.The seal reportedly showed evidence of energy delivery but bled at gastro-diaphragmatic vessels, back of the left pillars after cutting, and the sealing time of the vessel was observed to be short.It was noted that the jaws were cleaned approximately four times during the procedure.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (imf - f0801) 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 LS10
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25312003
• Report Number: 3006451981-2026-00043
• Device Sequence Number: 10545000
• Product Code: GEI
• UDI-Device Identifier: 10884521512801
• UDI-Public: (01)10884521512801(11)161108
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: 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: 05/04/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 11/08/2016
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Life Threatening
• Patient Sex: Male