MAUDE Adverse Event Report: BUFFALO FILTER VIROVAC; APPARATUS, EXHAUST, SURGICAL

Model Number VV120

Device Problem Self-Activation or Keying (1557)

Patient Problem Burning Sensation (2146)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

We were using the suction cautery pencil tip (pencl plm surg bla 10 (plp 2020)) during the procedure with buffalo filter virovac and valley lab cautery machine.Surgical pencil began activating on its own without button being depressed.This was noticed by the audible tone.This resulted in a burn through the surgical gown of the resident in the field.The resident scrubbed out and was not injured as a result of the gown burn.The clip connecting the virovac to the cautery cord was disconnected and the pencil continued to be constantly activated without the button being pressed.The cautery handpiece was completely disconnected from both machines, removed from the surgical field and replaced with a new handpiece.The wrapper was given to the department nurse educator for tracking.The new handpiece functioned appropriately for a while without incident, but then also began to activate without being pressed.The black clip cord was removed from the cautery plug in the valley lab and also unplugged from the back of the virovac so as not to have artificial suction being activated as artifact from the electrical current in close proximity.Therefore, using the suction cautery handpiece without the suction capability.This so far has worked without incident.No harm reached the patient.Htm evaluated sensor and could find no issue.

• Brand Name: VIROVAC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): BUFFALO FILTER; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16042302
• MDR Text Key: 306085814
• Report Number: 16042302
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2022

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 Model Number: VV120
• Device Catalogue Number: VV120
• Device Lot Number: V07609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1