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

Model Number	VLLS10GEN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: lf1937, jaw lap lf1937 ligasure maryland 37cm (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
According to the reporter, day one of post operative sleeve gastrectomy, the consultant trailed lf1937 on the first patient and the patient's hemoglobin (hb) levels dropped from 149 to 115.Patient needed a reoperation to figure out where the bleed was coming from (hence the delay in reporting as surgeon were not aware of the reason for post op bleed).Patient had lost three liters of blood in abdomen which was a omentus venous slow bleed from short gastrics near the spleen.Otherwise, staple lines and port sites were normal.Post op reoperation did not take place immediately, as such surgeon needed to await confirmation from the healthcare professional as this could have been caused by anything.No blood transfusion performed.Reoperation was carried the following day and the insurgent seal took over two hours to find that the bleed came from a branch from short gastric which was the device was the only instrument used around the bleeding site during the initial procedure.The surgeon noted that during the procedure, the device worked as it should and the surgeon did not experience any incomplete seal notifications etc, normal tones observed such activation tones heard, no re-grasp, end tones observed.Patient did not receive chemo therapy.

• 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: 19997525
• Report Number: 3006451981-2024-00114
• Device Sequence Number: 7258081
• Product Code: GEI
• UDI-Device Identifier: 10884521512801
• UDI-Public: 10884521512801
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 08/15/2024

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: 07/25/2024
• Initial Report FDA Received Date: 08/15/2024
• Date Device Manufactured: 03/19/2018
• 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: Required Intervention; Other
• Patient Sex: Unknown