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

Lot Number 13941493

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

Ligasure maryland (lot number: 13941493) stopped working and the error message read, "cycle incomplete".Fda safety report id# (b)(4).

• Brand Name: LIGASURE MARYLAND
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC.
• MDR Report Key: 15632963
• MDR Text Key: 302123467
• Report Number: MW5112728
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• 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: 10/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 13941493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White