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

Model Number LF5637

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2024

Event Type  malfunction  

Event Description

From staff: ligasure broke inside of patient while surgeon was operating.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 18666891
• MDR Text Key: 334885709
• Report Number: 18666891
• Device Sequence Number: 1
• Product Code: GEI
• 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: 01/23/2024

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 Catalogue Number: LF5637
• Device Lot Number: 32560212X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 106 KG