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

Model Number	3971
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an intrapelvic tumor resection (sarcoma) procedure, 9 of 10 firings for intrapelvic tumor resection (sarcoma) were successful.At the second firing in question, for small intestine resection, the surgeon fired the device and the knife resected the tissue, however no staple was fired on it.No staple fell into the cavity, either.Then the surgeon clamped the cut end of small intestine with forceps and sutured it manually.Oozing bleeding occurred as a result of the issue.The status of the patient is no problem.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.There were no abnormalities observed during product analysis.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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: 6951232
• Report Number: 2647580-2017-07189
• Device Sequence Number: 899032
• 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,Followup
• Report Date (Section B): 01/08/2018

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: 02/28/2022
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Device Lot Number: P7B1124X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1