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 Tissue Damage (2104); Blood Loss (2597); Bowel Perforation (2668)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

Title: achievement of surgical proficiency in laparoscopic surgery for early endometrial cancer by gynecologic oncologists source: kurume medical journal vol.66, no.1 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between october 2015 and april 2017, 38 patients who underwent laparoscopic surgery with pelvic lymphadenectomy for endometrial cancer was analyzed.All patients underwent an extended simple hysterectomy.The ligasure device was used to seal the fallopian tubes and then the hysterectomy was performed using ligasure maryland device, monopolar and bipolar energy devices.Post-operative complications included: one patient had a serious grade 3 perforation of the sigmoid colon which was treated with an emergent laparotomy, 2 patients had estimated blood loss (ebl) greater that 500ml (one which was due to an iliac vein injury), and one patient had an injury of vessels.

• 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: 10766733
• MDR Text Key: 214150123
• Report Number: 1717344-2020-01316
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 10/08/2020
• 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: 56 YR