MAUDE Adverse Event Report: COOPERSURGICAL, INC. CARTER-THOMASON; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	CTI-512N
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Closure procedure kit with suture passer and two guides.Lot: 15942613.The passer closure device broke in two, essentially reducing control and making a small cut in the surface of the liver.Physician coagulated the cut with a surgical cautery unit to cause hemostasis.No other issue occurred, and patient left the suite without any other complication.

• Brand Name: CARTER-THOMASON
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr; trumbull CT 06611
• MDR Report Key: 20598179
• Report Number: 20598179
• Device Sequence Number: 15094961
• Product Code: GCJ
• UDI-Device Identifier: 60888937000094
• UDI-Public: (01)60888937000094
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2024
• Report Date (Section F): 07/30/2024

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: CTI-512N
• Device Catalogue Number: CTI-512N
• Device Lot Number: 15942613
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/30/2024