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

Model Number LF1944

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2021

Event Type  malfunction  

Event Description

During use of the ligasure vessel sealing device the unit malfunctioned and caused a delay in sealing the vessel resulting in the need to utilize another unit and hand piece.Fda safety report id# (b)(4).

• Brand Name: MARYLAND JAW LAPROSCOPIC SEALER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12615856
• MDR Text Key: 276239623
• Report Number: MW5104529
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1944
• Device Catalogue Number: LF1944
• Device Lot Number: 11390175X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR