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

Model Number	FG-025310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombus (2101); Blood Loss (2597)
Date of Event	01/31/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Spent (empty) staple strips were found in all three (3) returned microcutter 30 white reloads indicating that all cartridges had contained staples.No staple jam or non-deployed staples were found in the three (3) returned reloads and all staples were deployed.No abnormality was found with the returned stapler.The lock-out mechanism on the returned stapler was tested and was confirmed to be working properly.Note: per the design of the stapler's lock-out mechanism, the microcutter 5/80 stapler will not clamp without a compatible, un-deployed microcutter 30 reload loaded into the stapler, and without the wedge of the compatible reload positioned all the way at the proximal end.If the stapler is not clamped, the stapler knife will not advance, thus preventing the tissue from being cut.Functional testing was conducted using a demonstration microcutter 30 reload.When loaded with the demonstration microcutter 30 reload and fired on test material, the staples deployed and formed properly.
Event or Problem Description
During an open right hemihepatectomy the microcutter 5/80 stapler was used to deploy staples from two microcutter 30 reloads without incident.A third reload was used to transect the right portal vein in close proximity to where the vessel bifurcates from the portal vein.The vessel was transected with the stapler but it was reported that staples were not present resulting in an estimated blood loss of 600 ml.The bleeding was controlled by suturing and the operation was completed.At the end of the surgery, insufficient flow was noted in the left portal vein and a re-anastomosis of the left portal vein was completed, which resulted in sufficient flow in the left portal vein.In the post-operative period, the patient was reported to develop retrograde thrombus in the portal vein and had surgery to relieve the portal vein narrowing.The patient experienced a second post-operative incidence of thrombus and subsequently expired.

• Brand Name: MICROCUTTER 30 WHITE RELOAD
• Common Device Name: STAPLE
• Manufacturer (Section D): DEXTERA SURGICAL INC; 900 saginaw drive; redwood city CA 94063
• MDR Report Key: 6370961
• Report Number: 3004114958-2017-00002
• Device Sequence Number: 694401
• Product Code: GDW
• UDI-Device Identifier: 11814900003117
• UDI-Public: 0111814900003117
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K161137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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 Model Number: FG-025310
• Device Catalogue Number: FG-025310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEXTERA MICROCUTTER 5/80 STAPLER, FG-025302
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 72 YR