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	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The system was removed from the box and a brown substance was noticed in the peel pack.It was not placed on the sterile field and did not cause any delays.

• Brand Name: CLEARIFY
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 21934072
• Report Number: 21934072
• Device Sequence Number: 7893525
• Product Code: GCJ
• UDI-Device Identifier: 10884521213562
• UDI-Public: (01)10884521213562
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/22/2025
• Report Date (Section F): 04/22/2025

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
• Device Model Number: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: D4M2407Y
• 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: 04/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• 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 Age: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/22/2025