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

Model Number VLLS10GEN

Device Problem Energy Output Problem (1431)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/03/2024

Event Type  malfunction  

Event Description

According to the reporter, during a procedure, inability to complete sealing and bleeding were observed. the device constantly gave the warning that the sealing had been completed but sealing was not completed and the patient bled after cutting.The vessel was not fully transected using the first device, while vessel was fully transected on the second device.Bleeding observed directly from the seal.

Manufacturer Narrative

D10 concomitant products: lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot #40380210x) lf1923, jaw open lf1923 ligasure maryland 23cm, (lot #32350293x).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
• Type of Device: 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: 19198209
• MDR Text Key: 341635829
• Report Number: 3006451981-2024-00056
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521780583
• UDI-Public: 10884521780583
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K143654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLLS10GEN
• Device Catalogue Number: VLLS10GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• 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 H11