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); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

Title: pregnancy outcome after emergency uterine artery embolisation for management of intractable haemorrhage associated with laparoscopic -assisted myomectomy source: journal of obstetrics and gynaecology, 2020, vol.40, no.8, 1111¿1117 https://doi.Org/10.1080/01443615.2019.1706156.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed from january 2007 through august 2017 to analyze the safety and efficacy of emergency uterine artery embolization (uae) for intractable hemorrhage in patients who underwent laparoscopic-assisted myomectomy patient.There were 764 patients and complications included: intra-operative bleeding/hemorrhage, post-operative hematoma and infection requiring antibiotics.Bleeding was treated with transfusions, evaluation with ct angiography and emergency uterine artery embolization.

• 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: 11301574
• MDR Text Key: 230968730
• Report Number: 1717344-2021-00204
• 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,user facil
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 01/15/2021
• 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: 34 YR