MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number LF1212A

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

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Title: the efficacy of ligasuretm open instruments in cases of cesarean hysterectomy due to placenta percreta: a retrospective, record-based, comparative study source: the journal of maternal-fetal & neonatal medicine published online: 30 nov 2020 if information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study compared hysterectomies performed with traditional cutting and tying tools and th ose performed with ligasure instruments in patients with known with placental insertion anomalies between 2013 and 2019.There were 28 patients in the ligasure group and post-operative complications included: transfusions, bladder repair and post-operative infection.Interventions for bladder repair and infection not listed.

• Brand Name: LIGASURE
• 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: 11249965
• MDR Text Key: 229285862
• Report Number: 1717344-2021-00135
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20884521186030
• UDI-Public: 20884521186030
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K152286
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• 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