MAUDE Adverse Event Report: COVIDIEN LIGASURE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number LF5637

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  malfunction  

Event Description

Patient was brought to the operating room and was laid supine on the operating table.The patient was induced with general endotracheal anesthesia without complication.The abdomen was prepped and draped in the usual sterile fashion.Timeout procedure was performed.The procedure started with insufflation of the abdomen.Various trocars were placed in different ports.When the time came for the use of the ligasure, there was an issue encountered.Per md, ligasure worked but hook did not work at all.The device was replaced with another similar device and the procedure was completed without any further incident.No patient harm.Manufacturer response for electrosurgical, cutting coagulation accessories, ligasure (per site reporter).Device retrieved by field representative.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16794936
• MDR Text Key: 313818766
• Report Number: 16794936
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521735
• UDI-Public: (01)10884521521735(17)280202(10)30340053X
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2023,03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF5637
• Device Lot Number: 30340053X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Hispanic