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 Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

Title comparison between caïman® and ligasure® in laparoscopic sleeve gastrectomy: a retrospective study of 200 patients source obes surg, date of publication: 16 april 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed january 2019 and december 2019, a study was done to retrospectively compare in traoperative performance, post-operative results, and clinical outcomes of device (la ) in a large cohort of patients undergoing laparoscopic sleeve gastrectomy (lsg).There were 200 patients included in the study, 100 of them were operated using non-medtronic product, and the other 100 were operated using la.Four complications were reported in the device group including one hemorrhage with reoperation, two hemorrhage, and one with fistula/abscess.

• 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: 10195629
• MDR Text Key: 196440185
• Report Number: 1717344-2020-00664
• 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: Other
• Type of Report: Initial
• Report Date: 06/25/2020

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: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention