MAUDE Adverse Event Report: COVIDIEN LIGASURE ATLAS TISSUE FUSION LAPAROSCOPIC INSTR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number SOF0001PX

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2021

Event Type  malfunction  

Event Description

Ligasure atlas not cauterizing.Fda safety report id# (b)(4).

• Brand Name: LIGASURE ATLAS TISSUE FUSION LAPAROSCOPIC INSTR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11602128
• MDR Text Key: 243638223
• Report Number: MW5100464
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: SOF0001PX
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR