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

Model Number LF5637

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Pneumonia (2011); Blood Loss (2597); No Code Available (3191)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

Title: perioperative outcomes of video- and robot-assisted segmentectomies source: asian cardiovascular & thoracic annals 2016, vol.24(2) 145¿151.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Pli 50: according to the literature study performed, from 2010 the video-assisted thoracic surgery (vats) appears to be technically difficult for segmentectomy.Robotic surgery could facilitate the performance of segmentectomy.The aim of this study was to compare the surgical outcomes of video- and robot-assisted segmentectomies.Data were collected prospectively on video thoracoscopy from 2010 and on robotic procedures from 2013.The utility incision allowed the introduction of one or two instruments and extraction of the specimen at the end of the intervention.They dissected with an electrothermal bipolar tissue-sealing system (ligasure or covidien) or with a coagulating hook.The non medtronic robotic surgical system was used for rats segmentectomy.Fifty-one patients (32 video- and 16 robot-assisted) who were candidates for minimally invasive segmentectomy were included in the study.Five patients had minor postoperative complications (ranks i and ii): 1 prolonged air leak, 1 atrial fibrillation, 1 pneumonia, and 2 paralyses of the left recurrent laryngeal nerve.Nine patients had major postoperative complications (ranks iii and v): 4 bronchoscopies for atelectasis, 3 transfers to the intensive care unit for noninvasive ventilation, 1 reoperation for air leak.The vats procedure was converted to a thoracotomy to control the bleeding (550ml blood loss) and a lingual-sparing left upper lobectomy was converted to lobectomy.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed from april 2010 to june2014, the video-assisted thoracic surgery (vats) appears to be technically difficult for segmentectomy.Robotic surgery could facilitate the performance of segmentectomy.The aim of this study was to compare the surgical outcomes of video- and robot-assisted segmentectomies.Data were collected prospectively on video thoracoscopy from 2010 and on robotic procedures from 2013.The utility incision allowed the introduction of one or two instruments and extraction of the specimen at the end of the intervention.They dissected with an electrothermal bipolar tissue-sealing system (ligasure or covidien) or with a coagulating hook.The non medtronic robotic surgiical system was used for rats segmentectomy.Fifty-one patients underwent minimally invasive segmentectomies ( 32 video- and 16 robot-assisted procedures; plus 3 segmentectomies [2 video-assisted and 1 robot-assisted] were converted to lobectomies) were included in the study.Five patients had minor postoperative complications (ranks i and ii): 1 prolonged air leak, 1 atrial fibrillation, 1 pneumonia, and 2 paralyses of the left recurrent laryngeal nerve.Nine patients had major postoperative complications (ranks iii and v): 4 bronchoscopies for atelectasis, 3 transfers to the intensive care unit for noninvasive ventilation, 1 reoperation for air leak.The vats procedure was converted to a thoracotomy to control the bleeding (550ml blood loss).

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9700919
• MDR Text Key: 180174978
• Report Number: 1717344-2020-00144
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521735
• UDI-Public: 10884521521735
• Combination Product (y/n): N
• PMA/PMN Number: K161804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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
• Device Operator: Health Professional
• Device Model Number: LF5637
• Device Catalogue Number: LF5637
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR