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

Catalog Number LF1823

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2021

Event Type  malfunction  

Event Description

Ligasure lf1823 did not function- sound activated but no power.Check instrument screen flashing.

Event Description

Ligasure lf1823 did not function- sound activated but no power.Check instrument screen flashing.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11715205
• MDR Text Key: 247093523
• Report Number: 11715205
• Device Sequence Number: 1
• Product Code: GIE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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 Catalogue Number: LF1823
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2021
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 69