MAUDE Adverse Event Report: COVIDIEN LP CLEARIFY; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	21-345
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to patient entering or (operating room), the surgical tech turned on the clearify visualization system.It began smoking and was hot to the touch.The device was immediately turned off and removed from the operating room.

• Brand Name: CLEARIFY
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 20662078
• Report Number: 20662078
• Device Sequence Number: 20654453
• Product Code: GCJ
• UDI-Device Identifier: 10884521213562
• UDI-Public: (01)10884521213562(17)260228(10)D4C3277Y
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/24/2024
• Report Date (Section F): 10/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: 21-345
• Device Lot Number: D4C3277Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 10/24/2024