MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Model Number 65410-181

Device Problems Fire (1245); Overheating of Device (1437); Defective Device (2588)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

The patient was undergoing a vasectomy, when the physician reported the cautery pen feeling very hot in his hand and had asked for a different cautery.While getting a new cautery pen out the drawer, a 4x4 gauze on the sterile field was noted to be burning.The physician removed the sterile field from the patient¿s lap.Once drapes were on the floor, the 4x4¿s were stamped to ensure the fire was out.The patient was without injury and the procedure was continued.The defective cautery pen was sequestered.

• Brand Name: CARDINAL HEALTH
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 14345278
• MDR Text Key: 291284154
• Report Number: 14345278
• 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: 05/06/2022

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 Operator: Health Professional
• Device Model Number: 65410-181
• Device Catalogue Number: 65410-181
• Device Lot Number: 0520G
• 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: 05/06/2022
• Event Location: Other
• Date Report to Manufacturer: 05/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Sex: Male