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

Model Number	3971
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the surgeon fired the device, the knife was advanced and the tissue was fully resected ,however the stapling was incomplete.The staples were malformed in u-formed or m-formed.As the cut end were unstapled ,the surgeon manually sutured the incomplete staple line.Surgical time was extended by more than 30 minutes and oozing bleeding occurred as a result.No injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No visual abnormalities were noted during evaluation.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer¿s quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures; therefore, a device history record will not be performed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• 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: 7094978
• Report Number: 2647580-2017-08458
• Device Sequence Number: 1933752
• Product Code: GDW
• UDI-Device Identifier: 10884521063167
• UDI-Public: 10884521063167
• 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,Followup
• Report Date (Section B): 01/25/2018

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: 02/28/2021
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Device Lot Number: P6B0646X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1