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

Model Number	EEAXL2835
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic robotic sigmoid colectomy, on sigmoid colon, the device partially fired.The surgeon first used our circular stapler and the staple line was incomplete.Upon second attempt, the surgeon used a competition's circular stapler and staple line was incomplete.On third attempt, the surgeon used another one of our circular stapler again and staple line was also incomplete.Upon fourth attempt, the surgeon used another circular stapler and performed a side to end anastomosis and staple line was complete.Flexible sigmoidoscopy revealed a patent well-perfused anastomosis, leak test was fine and donuts were good.On the outside, they had enough redundancy so that the colon was reaching without any tension, but the cut end of the colon was bleeding.However, coloproctostomy was at ten centimeters from the anal verge.A diverting loop ileostomy was also done to protect the anastomosis and to mitigate the effect of any potential leak in the future.The ileostomy will be re-anastomosed in the future.The surgery was extended by three hours and the patient stayed in the hospital for seven days.
Additional Manufacturer Narrative
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: 7718904
• Report Number: 2647580-2018-03729
• Device Sequence Number: 11039772
• Product Code: GDW
• UDI-Device Identifier: 10884523006148
• UDI-Public: 10884523006148
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 87