MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SURGICAL CAUTERY - FINE TIP/HIGH TEMP; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Model Number 65410-181

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

While doing a subungual hematoma procedure, a flame presented with immediate use of cautery stick.Flame extinguished within one second.No damage to patient's finger or nail, photos obtained and cautery stick numbers entered in chart.Repeated procedure with a new cautery stick, procedure successful.

• Brand Name: SURGICAL CAUTERY - FINE TIP/HIGH TEMP
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 13885432
• MDR Text Key: 287802004
• Report Number: 13885432
• Device Sequence Number: 1
• Product Code: HQP
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65410-181
• Device Catalogue Number: 65410-181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2022
• Date Report to Manufacturer: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1