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 Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a hemicolectomy, on anastomoses, the device partially fired and there was an incomplete staple line.They manually over sewed using a traditional sutures to fix the staple line.The surgical time was extended by 1-2 hours.
Additional Manufacturer Narrative
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: 7762810
• Report Number: 2647580-2018-03949
• Device Sequence Number: 19271685
• Product Code: GDW
• UDI-Device Identifier: 10884521063167
• UDI-Public: 10884521063167
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K885222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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