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 Code	Blood Loss (2597)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two staplers and three white reloads were returned for evaluation.Note: reload #3 was not used in the surgical procedure but was returned due to an issue when attempting to load it into the stapler.Physical examination of the returned staplers and reloads and a review of manufacturing documentation demonstrated that the devices met specifications.Examination of reloads #1 and #2 demonstrated the wedges were at the distal end of the cartridges, confirming deployment of the staples.All staples appeared to have appropriately sheared from the staple cartridge and there was no evidence of staple jamming.Examination of reload #3 (not used in the surgical procedure) demonstrated a broken piece of the loader in the cartridge and it was noted that the wedge had only moved forward slightly.Functional testing was conducted using representative white reloads in both staplers.Functional testing demonstrated that the staplers worked properly and staples from the representative white reloads formed properly.The complaint could not be replicated.
Event or Problem Description
The procedure was a robotic left lower lobectomy.The microcutter 5/80 stapler was loaded with a microcutter 30 white reload and was positioned for transection of the inferior (lower lobe) pulmonary vein.A braided silk suture was used to facilitate placement of tissue into the device and was then removed prior to firing the stapler.Upon initial inspection, the staple line was hemostatic on both the patient and the specimen sides of the transection.The surgeon manipulated the lobe post transection of the inferior pulmonary vein (ipv) and oozing was noted on the specimen side of the staple line.Oozing was controlled by using a covidien stapler.The patient side of the transection remained hemostatic.The surgeon continued with the surgical procedure including transecting the superior segmental artery using a microcutter 5/80 stapler.The lung specimen was removed from the patient.Approximately 45 to 60 minutes after transecting the ipv and after removing the specimen, the lower lobe hilar region began to bleed.The patient was converted to an open thoracotomy and the surgeon communicated the area of concern was the inferior pulmonary vein.He wasn't able to visualize the staple line when he repaired the ipv.It was reported that there were no additional patient complications as a result of the bleeding.

• Brand Name: MICROCUTTER 30 WHITE RELOAD
• Common Device Name: STAPLE
• Manufacturer (Section D): DEXTERA SURGICAL INC; 900 saginaw dr.,; redwood city CA 94063
• MDR Report Key: 6655512
• Report Number: 3004114958-2017-00005
• Device Sequence Number: 1306488
• Product Code: GDW
• UDI-Device Identifier: 11814900003100
• UDI-Public: 0111814900003100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2017

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: 01/20/2019
• Device Model Number: FG-025310
• Device Catalogue Number: FG-025310
• Device Lot Number: 170119A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/20/2017
• 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: Other; Required Intervention