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

Model Number	FG-025310
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of risk management documents identifies the potential for this type of device malfunction, and the occurrence rate specified in the risk management documents accurately reflects the current actual occurrence rate.
Event or Problem Description
The surgeon was performing an open thoracotomy.The microcutter 5/80 stapler and a microcutter 30 curved tip blue reload were used to divide a basal branch of the pulmonary artery with acceptable results.The stapler and the microcutter 30 white reload were then used to divide a small segmental pulmonary artery branch with resultant bleeding noted at the patient side of the staple line.There did not appear to be any bleeding from the specimen side of the segmental pulmonary artery branch division.The surgeon reported that there did not seem to be any staples present in the vessel.The surgeon then placed sutures on both sides of the transected segmental pulmonary artery branch.A different stapler and different reloads were used to complete the surgery.There were no reported complications.

• 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: 6462709
• Report Number: 3004114958-2017-00003
• Device Sequence Number: 582783
• Product Code: GAG
• UDI-Device Identifier: 01814900003103
• UDI-Public: 0101814900003103
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/08/2018
• Device Model Number: FG-025310
• Device Catalogue Number: FG-025310
• Device Lot Number: 161207C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/05/2017
• 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