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

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problems Pulmonary Embolism (1498); Arthritis (1723); Unspecified Infection (1930); Pneumonia (2011); Thromboembolism (2654)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

Title single-port laparoscopic sleeve gastrectomy as a routine procedure in 1000 patients source surgery for obesity and related diseases, volume 12, 2016 (1270-1277) article number: 7 date of acceptance: 12 january 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, the aim of the study was to report surgical results and follow-up outcome after single-port laparoscopic sleeve gastrectomy (spsg) to treat obesity in 1000 patients.The device was used for dissection of gastrocolic ligament and gastroepiploic vessels.Post-operatively, one patient suffered from venous thromboembolic disease and had been successfully treated the year before the intervention by oral anticoagulation for pulmonary embolism.Post-operative complications in 15 patients include: 5 patients had unexplained post-operative fever, 3 patients had pulmonary embolism, 4 had wound infection, 1 had diabetic ketoacidosis, 1 had pneumonia, and 1 had acute gouty arthritis.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10291839
• MDR Text Key: 199740015
• Report Number: 1717344-2020-00752
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 118