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

Model Number	CTI-1015P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During closure carter thomason handpiece broke and became usable.All pieces are attached and no pieces were separated from handpiece.Handpiece taken to quality.

• Brand Name: CARTER-THOMASON II PORT CLOSURE SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8270112
• Report Number: 8270112
• Device Sequence Number: 13488158
• Product Code: GCJ
• UDI-Device Identifier: 60888937002920
• UDI-Public: (01)60888937002920(10)238791(17)231009
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2018
• Report Date (Section F): 12/18/2018

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-1015P
• Device Lot Number: 238791
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 12/18/2018