MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/22/2021

Event Type  Injury  

Event Description

According to the literature, a retrospective study analyzed outcomes of patients who underwent retrosigmoid ileal conduit after open radical cystectomy for bladder cancer between march 2016 and june 2020.The mesentery incision was performed using ligasure.97 patients were in the study and complications included: post-operative bleeding (1), small bowel obstruction (2), sepsis (1), and ileal anastomotic dehiscence (1), wound infection (5).Surgical revision was required for small bowel obstruction (with ileal resection) and postoperative bleeding, blood transfusions were reported in 15 patients (15.5%) and icu management was required for sepsis and anastomotic dehiscence.

Manufacturer Narrative

Title: retrosigmoid ileal conduit without transposition of the left ureter after open radical cystectomy for bladder cancer.Source: bju int 2022; 129: 48¿53.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13723644
• MDR Text Key: 286988688
• Report Number: 1717344-2022-00291
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/10/2022

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: 02/23/2022
• Initial Date FDA Received: 03/10/2022
• 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: 75 YR
• Patient Sex: Male