MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number VLFT10GEN

Device Problem Energy Output Problem (1431)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 04/05/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, they used exact, the sealing wasn't good enough and they had to use manual sutures to ensure hemostasis.Transfusion was not necessary.They changed the generator but the issue persisted.There was no regrasp alert.There was an end tone heard reported and there was an evidence of energy delivery.The patient also had bruise.

• Brand Name: VALLEYLAB FT10
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14258347
• MDR Text Key: 290475352
• Report Number: 1717344-2022-00521
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: 10884521516328
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Date Device Manufactured: 10/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other