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 Problem No Code Available (3191)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Title: does reduced-port laparoscopic surgery for medically uncontrolled ulcerative colitis do more harm than good? source: asian j endosc surg 91 (2016) 24¿31 accepted 10 september 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of the study, performed between may 2011 and september 2014, 10 ulcerative colitis (uc) patients underwent single-incision plus one port laparoscopic surgery (sils + 1).All procedures were performed using a 5-mm standard definition flexible scope, ultrasonic-activated scissors, activating laparoscopic coagulating shears, and straight and curved graspers.The end of the ileum was cut with the reported stapler, and the ascending colon was mobilized to the hepatic flexure with a retroperitoneal approach.Transanal mucosectomy was performed above the dentate line, and the circumferential muscular layer of the rectum was transected with a stapling device or two firings of a linear cutting roticulating stapler.Post-operatively, one patient had (b)(6) enteritis which resolved with conservative management.

• 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: 10292692
• MDR Text Key: 199738736
• Report Number: 1717344-2020-00753
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/17/2020

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: 06/24/2020
• Initial Date FDA Received: 07/17/2020
• 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: 32 YR