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

Model Number LF1937

Device Problem Defective Device (2588)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Disposable maryland ligasure was defective during this patient's surgery.It did not cut or coagulate at all.A new disposable ligasure was opened and worked correctly.Serial number: (b)(4), lot number: 14035061.Fda safety report id# (b)(4).

• Brand Name: LIGASURE MARYLAND JAW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 15806954
• MDR Text Key: 303909922
• Report Number: MW5113315
• 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: 11/14/2022

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 Operator: Health Professional
• Device Model Number: LF1937
• Device Lot Number: 14035061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1