MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SCD7A26
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right lobe liver resection and cholecystectomy, the patient's vena cava was injured, causing major blood loss.The procedure involved the use of the sonicision 7 device.The surgeon started transection with a bovie, going ~1cm deep.Then used the sonicision 7 to transection ~2-3cm deeper, and finished the transection with the egiaustnd + 11 sig30avm reloads.The specimen was removed and sent to pathology to assess margins.Laps were placed against the resected liver and compression was held for 10 minutes.The laps were removed to assess the liver, and this is when the surgeon realized the hole in the vena cava.The estimated blood loss was approximately 1.5 liters.Efforts to control hemorrhage were initiated and code blue was activated.A vascular surgeon was consulted intraoperatively and successfully repaired the vena cava defect with sutures, achieving hemostasis.The surgical site was left temporarily open, and a wound vacuum-assisted closure (vac) device was applied, with definitive closure completed later.The was patient was stabilized in the icu postoperatively and subsequently discharged in stable condition.
Additional Manufacturer Narrative
D10 concomitant products: scba, battery scba (serial#: unknown), scg7ab, sonicision 7 generator b scg7ab (serial#: unknown), sig30avm, tri 2.0 sig30avm 30 vsclr med 12mm (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.

• Brand Name: SONICISION
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21902737
• Report Number: 1717344-2025-00596
• Device Sequence Number: 8794908
• Product Code: LFL
• UDI-Device Identifier: 10884521794788
• UDI-Public: 10884521794788
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SCD7A26
• Device Catalogue Number: SCD7A26
• Device Lot Number: 42830238X
• 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: 04/09/2025
• Initial Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Other; Hospitalization
• Patient Sex: Unknown