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

Model Number	LS1200
Medical Device Problem Codes	Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	02/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Title: is sutureless thyroid surgery safe in the hands of surgical trainees.A single centre retrospective study source: ambe and wassenberg bmc res notes (2016) 9:118 doi 10.1186/s13104-016-1940-7.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pli 10: according to literature source of study performed from january 2011 until october 2013, two hundred and eight patients underwent thyroid surgery.Surgery was performed in 147 cases (70.7 %) by consultants (consultant group) and in 61 cases (29.3 %) by surgical trainees (trainee group).The ligasure® precise (covidien, boulder, co, usa) was used in all cases.The rate of postoperative hemorrhage was 3.4 % (7/208).And the incidence of permanent recurrent laryngeal nerve injury was 0.9 % (2 cases).

• Brand Name: LIGASURE PRECISE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9207398
• Report Number: 1717344-2019-01369
• Device Sequence Number: 449537
• Product Code: GEI
• UDI-Device Identifier: 10884524001463
• UDI-Public: 10884524001463
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K010010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 10/02/2019
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR