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

Model Number VLFT10GEN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problem Hematoma (1884)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, the pencil was not cutting as it typically did and was slow and inadequate.Cords were checked, and it was observed that the tones did not sound like the usual pencil during activation.The surgeon tried to continue with procedure, but was not getting tissue effect and asked to have cut/coag turned up from 25/25 (typical setting) to 40/40.The issue persisted and the other tip was opened and inserted in original pencil with same results.The surgeon finished the procedure with the 2nd tip not functioning/cutting well, at a setting of 40/40.The patient developed a hematoma post operatively which was observed at check up.The patient had a bleeding less than 250cc and developed a hematoma post op which was observed at first post op check up.

• Brand Name: VALLEYLAB FT10
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10731713
• MDR Text Key: 213035059
• Report Number: 1717344-2020-01266
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: 10884521516328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2020
• Is this an Adverse Event Report?: No
• 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: 10/06/2020
• Date Device Manufactured: 10/01/2016
• 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