MAUDE Adverse Event Report: CONMED CORPORATION BUFFALO FILTER CAUTERY PEN; APPARATUS, EXHAUST, SURGICAL

Device Problems Fire (1245); Sparking (2595)

Patient Problem Blister (4537)

Event Date 03/25/2022

Event Type  Injury  

Event Description

Procedure performed: excision of right posterior neck soft tissue mass.Cautery was then used to assist with this portion of the dissection.During the dissection, there was noted to be a spark and an orange glow was noted.Rapid removal of the drapes and facemask revealed a surgical fire involving the face mask.There was no evidence of any obvious facial or airway burn.He expressed no ongoing pain or difficulty breathing.His oxygen saturations remained stable.An approximately one centimeter sized blister was noted on the patient's right posterior shoulder.Fda safety report id # (b)(4).

• Brand Name: BUFFALO FILTER CAUTERY PEN
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 14546941
• MDR Text Key: 292962252
• Report Number: MW5109967
• Device Sequence Number: 1
• Product Code: FYD
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic