MAUDE Adverse Event Report: DEXTERA SURGICAL INC DEXTERA MICROCUTTER 5/80 STAPLER; STAPLER, SURGICAL

Model Number	FG-025302
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for investigation which demonstrated the device was within specification and there was no anomaly or malfunction related to the device.
Event or Problem Description
The patient was undergoing a right lung middle lobectomy by robotic video-assisted thoracic surgery.The microcutter 5/80 stapler was advanced through the accessory port trocar to a branch of the superior pulmonary vein following dissection of tissue around the target vein.While positioning the stapler at the selected location for transection of the vein and prior to firing the stapler, bleeding occurs which appears to have originated from behind the target vein.It appears that a small branch vessel, located behind the target vein, may have avulsed when the microcutter 5/80 stapler was being positioned, resulting in bleeding.The stapler is subsequently fired resulting in a successful staple line.The surgeon then uses pressure to control the bleeding.Additional bleeding is noted at the distal end of the transected vessel.The surgeon controls the bleeding through the use of direct pressure, cautery, topical hemostatic agents and clips.The surgery was completed and it was reported that the patient did not experience any further complications as a result of the bleeding and is doing well.

• Brand Name: DEXTERA MICROCUTTER 5/80 STAPLER
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): DEXTERA SURGICAL INC; 900 saginaw drive; redwood city CA 94063
• MDR Report Key: 6580091
• Report Number: 3004114958-2017-00004
• Device Sequence Number: 74947
• Product Code: GAG
• UDI-Device Identifier: 11814900003025
• UDI-Public: 0111814900003025
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2019
• Device Model Number: FG-025302
• Device Catalogue Number: FG-025302
• Device Lot Number: 170206B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR