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

Model Number	21-345
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hair noted on visualization system.

• Brand Name: CLEARIFY
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 22529804
• Report Number: 22529804
• Device Sequence Number: 20701322
• Product Code: GCJ
• UDI-Device Identifier: 10884521213562
• UDI-Public: (01)10884521213562(17)270228(10)D5C4060Y
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/14/2025
• Report Date (Section F): 07/14/2025

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 Catalogue Number: 21-345
• Device Lot Number: D5C4060Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2025
• 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: Unknown
• Date Report Sent to FDA: 07/14/2025