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

Model Number	FG-025320
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation was conducted by the manufacturer on the returned devices.There were no malfunctions noted during the investigation of the stapler and empty blue cartridge that were specified as being used by the physician during the incident.A functional test was also conducted using the returned stapler with representative blue reloads.No issues were noted during deployment of the staples or with the deployed staple lines.
Event or Problem Description
The surgeon was performing a reversal of an ileostomy that was completed as part of a previous surgery by another surgeon.During this open procedure, the surgeon successfully used the microcutter 5/80 stapler to resect the mesentery and the ileum without issue.A blue reload was used for the second deployment of the side to side anastomosis (fifth deployment with the stapler).There were no issues noted during loading of the reload or when deploying the staples.Upon opening the stapler jaws, the surgeon noted the tissue to be sticking to the bottom stapler jaw.The physician's assistant used her thumb and index finger to carefully remove the tissue from the jaws, which allowed removal of the stapler.The staple line was inspected and slight oozing was noted but the surgeon determined the oozing to be clinically acceptable.The surgeon completed the side to side anastomosis.The common enterotomy was then closed with another type of stapler.At that point the surgeon noted a leak in the anastomosis and elected to resect the anastomosis and use hand suturing to complete a new one.The case was completed without any patient complications.

• Brand Name: MICROCUTTER 30 BLUE RELOAD
• Common Device Name: STAPLE
• Manufacturer (Section D): DEXTERA SURGICAL INC; 900 saginaw dr.,; redwood city CA 94063
• MDR Report Key: 6904971
• Report Number: 3004114958-2017-00008
• Device Sequence Number: 19104973
• Product Code: GDW
• UDI-Device Identifier: 11814900003209
• UDI-Public: (01)11814900003209
• Combination Product (Y/N): N
• 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): 09/29/2017

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: 05/17/2019
• Device Model Number: FG-025320
• Device Catalogue Number: FG-025320
• Device Lot Number: 170516B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/29/2017
• 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: 3 MO