MAUDE Adverse Event Report: DEXTERA SURGICAL INC. CARDICA C-PORT FLEX-A PLUS DISTAL ANASTOMOSIS; CARDIOVASCULAR SURGICAL INSTRUMENTS

Model Number	FG-000150
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546); Defective Component (2292); Failure to Fire (2610)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is now being filed due to additional information that was learned subsequent to the initial information provided by the user facility.The c-port xa (fg-000100) and c-port flexa (fg-000150) share the same design in respect to activation of clamping, deployment, and the energy source used to accomplish these actions.Thus, the same malfunction is noted in the two devices.
Event or Problem Description
During deployment of the device and while being held by the surgeon, the device handle broke into pieces, accompanied by a loud noise.There was no reported adverse event either to the patient or to user/surgical personnel.

• Brand Name: CARDICA C-PORT FLEX-A PLUS DISTAL ANASTOMOSIS
• Common Device Name: CARDIOVASCULAR SURGICAL INSTRUMENTS
• Manufacturer (Section D): DEXTERA SURGICAL INC.; 900 saginaw dr.,; redwood city CA 94063
• MDR Report Key: 7410270
• Report Number: 3004114958-2018-00002
• Device Sequence Number: 1052119
• Product Code: FZP
• UDI-Device Identifier: 11814900001502
• UDI-Public: 0111814900001502
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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 Expiration Date: 10/01/2019
• Device Model Number: FG-000150
• Device Catalogue Number: FG-000150
• Device Lot Number: 170907D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1