MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ILA; STAPLE, IMPLANTABLE

Model Number	3971
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of the device.Visual inspection noted the device was received partially fired.The knife assembly and white sleeve were disengaged.Functional testing was precluded due to the observed damage.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition occurs when the firing handle is over retracted after firing.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.This event was previously reported to the fda on a summary report and is now being submitted on a 3500a per fda request.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a proximal pancreaticduodenectomy procedure.For the first firing, the surgeon tried to fire the device to the stomach, however, could not.The procedure was completed with another device.There was no patient harm.The status of the patient is no problem.

• Brand Name: ILA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7104197
• Report Number: 2647580-2017-08642
• Device Sequence Number: 11058353
• Product Code: GDW
• UDI-Device Identifier: 20884521063164
• UDI-Public: 20884521063164
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Device Lot Number: P6L0408X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1