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 Unspecified Infection (1930); Blood Loss (2597); No Code Available (3191)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Title: feasibility and outcomes of opportunistic bilateral salpingectomy in patients with traditional relative contraindications to vaginal hysterectomy.Source: journal of minimally invasive gynecology.Vol 27, no 6, september/october 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature case study that retrospectively analyzed 258 patients who underwent a vaginal hysterectomy with or without removal of tubes and/or bilateral salpingectomy at a tertiary center in cleveland, ohio by 9 surgeons between 2014 and 2017.224 procedures were performed with salpingectomy, 34 patients did not undergo salpingectomy.Vascular pedicles were secured either by traditional clamp cut-tie technique or with the use of an advanced, bipolar vessel-sealing device (ligasure) with or without the round ligament technique.13 patients were readmitted due to surgical complications and 7 patients underwent re-operation.There were 44 reported post-operative complications including: 7 blood transfusions, vaginal cuff abcess, and infections.

• 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: 10766877
• MDR Text Key: 214110350
• Report Number: 1717344-2020-01318
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• 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: 10/12/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR