MAUDE Adverse Event Report: DEXTERA SURGICAL INC MICROCUTTER 30 CURVED TIP WHITE RELOAD; STAPLE

Model Number	FG-025311
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correct mfr report # and ensured initial reporter information was correct and present.
Event or Problem Description
The patient was undergoing a lobectomy through a robotic video-assisted thoracoscopic surgery (vats).The microcutter 5/80 stapler and a microcutter 30 reload were used on an initial vessel without issue.A second transection was done on the superior pulmonary vein.No bleeding was seen when the stapler jaws were initially opened, however, tissue appeared to be adhered to the lower jaw of the stapler.The surgeon then used robotic graspers to remove the tissue from the stapler jaw which was subsequently followed by bleeding.The procedure was converted to an open thoracotomy to control the bleeding.The patient lost approximately 1.5 liters of blood, received emergency treatment and received a blood transfusion.The procedure was completed and the patient was sent to the intensive care unit (icu).The patient was subsequently discharged from the icu in good condition.

• Brand Name: MICROCUTTER 30 CURVED TIP WHITE RELOAD
• Common Device Name: STAPLE
• Manufacturer (Section D): DEXTERA SURGICAL INC; 900 saginaw dr.,; redwood city CA 94063
• MDR Report Key: 8356560
• Report Number: 3004114958-2017-00006
• Device Sequence Number: 2127246
• Product Code: GDW
• UDI-Device Identifier: 01814900003110
• UDI-Public: 0101814900003110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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: No Information
• Device Expiration Date: 03/08/2019
• Device Model Number: FG-025311
• Device Catalogue Number: FG-025311
• Device Lot Number: 170307D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 02/20/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 45