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

Model Number LF2019

Device Problems Display or Visual Feedback Problem (1184); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Ligasure¿ exact dissector failed to connect electronically ¿ error message on two different coagulation machines; unable to use; removed from field and replaced.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 16067346
• MDR Text Key: 306333610
• Report Number: 16067346
• 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: 12/22/2022

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 Model Number: LF2019
• Device Lot Number: 22160169X
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1