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

Model Number	EEAXL2835
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic colon resection, the device was difficult or unable to load, also the white trocar tip would not attach to the stapler.They opened a new device to complete the case and resolve the issue.
Additional Manufacturer Narrative
Post market vigilance (pmv) received one device.The visual inspection of the staple guide noted the instrument had a full complement of staples.Further inspection noted that the green bar was not visible in the indicator window and the safety feature was engaged.The staple guide was observed to be attached to the instrument with no damage to the staple guide.After actuating the handle, the pusher fingers appeared to be intact and inspection under the microscope displayed no damage to the knife blade.The anvil of the instrument was observed to be not tilted and separated from the instrument.Further inspection of the anvil cutting ring showed no traces of knife impression and the ring was received intact.The trocar was attached to the anvil a depressed button.Additional information: if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The trocar was attached to the anvil with a depressed button.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 failure.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: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 6901532
• Report Number: 2647580-2017-06898
• Device Sequence Number: 13587840
• Product Code: GDW
• UDI-Device Identifier: 20884523006145
• UDI-Public: 20884523006145
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2018

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: 06/30/2021
• Device Model Number: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Device Lot Number: P6F0621KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 11/07/2017; 12/14/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 12/06/2017; 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1