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

Model Number	EEAXL2835
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Form Staple (2579)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Damage (2104); No Code Available (3191)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 colostomy reversal, after the stapler was fired they saw an opening in the anastomoses from 12 to 6.There was poor staple formation, the handle was fully squeezed and the donuts were complete.They resected, re-stapled and converted to an open procedure to fix the staple line.The anvil got stuck on the anastomotic lip upon removal.The anvil can be tilted after firing.The event lead to or extended the patient¿s hospitalization.They needed to have a colostomy for diversion.They had to excise the tissue to close the tissue damage.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection noted no abnormalities.Functionally, the instrument was reloaded with a full complement of staple and was applied to appropriate test media with a representative anvil showing acceptable results.Pusher-fingers and knife advanced when the handle was squeezed and the knife cut the media cleanly and completely and a full complement of staples was deployed and properly formed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 8300518
• Report Number: 2647580-2019-00645
• Device Sequence Number: 19244907
• Product Code: GDW
• UDI-Device Identifier: 10884523006148
• UDI-Public: 10884523006148
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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 Expiration Date: 06/30/2023
• Device Model Number: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Device Lot Number: P8F1412KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/03/2019
• Supplement Report FDA Received Date: 04/19/2019
• 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: Hospitalization; Required Intervention