MAUDE Adverse Event Report: MEDTRONIC /COVIDIEN VALLEYLAB¿ FT10 ENERGY PLATFORM COVDIEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLFT10GEN

Device Problems Unsealed Device Packaging (1444); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/22/2021

Event Type  Injury  

Event Description

Patient returned to the operating room for post op bleeding.Later discovered device failed to properly seal the operative vessel completely.Fda safety report id # (b)(4).

• Brand Name: VALLEYLAB¿ FT10 ENERGY PLATFORM COVDIEN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC /COVIDIEN
• MDR Report Key: 13025612
• MDR Text Key: 282605786
• Report Number: MW5106120
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 89 KG