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

Model Number	VLLS10GEN
Medical Device Problem Codes	Energy Output Problem (1431); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Additional information: a3a, b5, g3, h6 additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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, during hemicolectomy, inability to complete sealing and bleeding are observed.The device constantly gave the warning that the sealing has been completed, but sealing was not completed and the patient bleeds 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.No seal was completed.No blood transfusion required.Another device used successfully.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19198209
• Report Number: 3006451981-2024-00056
• Device Sequence Number: 8294578
• Product Code: GEI
• UDI-Device Identifier: 10884521780583
• UDI-Public: 10884521780583
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 06/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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.
• Patient Sex: Female