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 Hematoma (1884); Hernia (2240); Blood Loss (2597); No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Title: short-term outcomes of single-port versus conventional laparoscopic sleeve gastrectomy: a propensity score matched analysis source: surgical endoscopy (2020) 34:3978¿3985 published online: 8 october 2019.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed between january 2015 and december 2016, which compares the short-term outcomes of single port sleeve gastrectomy (spsg) versus conventional laparoscopic sleeve gastrectomy(clsg).1122 patients underwent sleeve gastrectomy in both institutions (610 spsg and 512 clsg).From each group, 314 patients were successfully matched.The single port sleeve gastrectomy (spsg) had 90-day complications of bleeding intra-abdominal or intraluminal (14) , incisional hernia (10), one patient that presented a post-operative hematoma treated by percutaneous drainage under local anesthesia and one respiratory distress.In conventional laparoscopic sleeve gastrectomy (clsg) there were bleeding intra-abdominal or intraluminal (7), incisional hernia (3) and two patients that presented a postoperative hematoma treated by percutaneous drainage under local anesthesia.Short-term outcomes of single-port versus conventional laparoscopic sleeve gastrectomy: a propensity score matched analysis | hadrien tranchart1,2 · lionel rebibo3,4 · martin gaillard1,2 · abdennaceur dhahri3,4 · panagiotis lainas1,2 ·jean-marc regimbeau3,4 · ibrahim dagher1,2 | department of minimally invasive digestive surgery, antoine béclère hospital, ap-hp, 157 rue de la porte de trivaux, 92140 clamart, france | received: 1 march 2019 / accepted: 26 september 2019 / published online: 8 october 2019.

• 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: 10676834
• MDR Text Key: 211259653
• Report Number: 1717344-2020-01197
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• 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
• Date Manufacturer Received: 09/24/2020
• 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
• Patient Age: 39 YR