MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH XCEL OPTIVIEW; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	2CB5LT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Trocar broke in half.

• Brand Name: ENDOPATH XCEL OPTIVIEW
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 9391779
• Report Number: 9391779
• Device Sequence Number: 16255452
• Product Code: GCJ
• UDI-Device Identifier: 10705036013730
• UDI-Public: (01)10705036013730
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/20/2019
• Report Date (Section F): 11/20/2019

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: 2CB5LT
• Device Catalogue Number: 2CB5LT
• Device Lot Number: T40H1X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/20/2019