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

Model Number	FG-025302-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Renal Failure (2041); Sepsis (2067); Respiratory Failure (2484)
Date of Event	11/30/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on the reported information, there was no malfunction or defect related to the device.Device not returned to manufacturer.
Event or Problem Description
The surgeon reported an adverse event that occurred during a right upper lobectomy and lower lobe wedge resection via a video-assisted thoracoscopic surgery (vats).While positioning the stapler behind the right upper lobe segmental pulmonary artery branch, the stapler was pushed somewhat forcefully and the vessel tore distal to the site targeted for transection of the vessel.The staples were then deployed in the proximal portion of the vessel, resulting in a successful staple line.The surgical procedure was converted to an open thoracotomy due to the distal tear and subsequent bleeding.Following the conversion, the surgeon observed that the staples remained intact and there was no issue with the distal staple line, however the tear was noted distal to the staple line.In a subsequent communication on (b)(6) 2017, the surgeon reported that the patient had expired.It was reported by the hospital personnel that the patient was expired from sepsis on (b)(6) 2016.

• Brand Name: MICROCUTTER 5/80 STAPLER
• Common Device Name: MICROCUTTER STAPLER
• Manufacturer (Section D): DEXTERA SURGICAL INC; 900 saginaw drive; redwood city CA 94536
• MDR Report Key: 6227739
• Report Number: 3004114958-2017-00001
• Device Sequence Number: 1070779
• Product Code: GDW
• UDI-Device Identifier: 11814900003025
• UDI-Public: (01)11814900003025
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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: Physician
• Device Expiration Date: 11/01/2018
• Device Model Number: FG-025302-12
• Device Catalogue Number: FG-025302-12
• Device Lot Number: 161026J
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR