MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE PRECISE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	LS1200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Emphysema (1832); Internal Organ Perforation (1987); Unintended Radiation Exposure (4565); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: subcutaneous cervicofacial emphysema following thyroid surgery source: images for surgeons 2584-2586.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature study, in a case that describes subcutaneous cervicofacial emphysema following thyroid surgery, 5 days post-operatively, the patient presented to a local hospital with sudden onset neck and face swelling after coughing.Computed tomography revealed extensive subcutaneous emphysema of the neck, face, upper thorax and mediastinum, with a possible site of tracheal perforation at the level of c7.The patient was prophylactically intubated for transport back to the metropolitan hospital.However, as the patient was never in any respiratory distress and the usual sequelae of the surgical emphysema is usually self-limiting, the patient was treated conservatively with intravenous antibiotics and extubated the next day.

• Brand Name: LIGASURE PRECISE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13894421
• Report Number: 1717344-2022-00348
• Device Sequence Number: 19260871
• Product Code: GEI
• UDI-Device Identifier: 10884524001463
• UDI-Public: 10884524001463
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: LS1200
• Device Catalogue Number: LS1200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Male