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

Model Number	EEAXL2835
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Damage (2104); Injury (2348); Bowel Perforation (2668); No Code Available (3191)
Date of Event	08/28/2019
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 post operatively, on a low anterior resection laparoscopy, the patient presented with an anastomotic leak that resulted in a colorectal leak and a failed anastomosis.The patient underwent a second surgical operation to repair the failed anastomosis.There was tissue damage.The patient was hospitalized.Another procedure was done to clean the area.There was a patient injury.

• 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: 9132551
• Report Number: 2647580-2019-04841
• Device Sequence Number: 11515184
• Product Code: GDW
• UDI-Device Identifier: 10884523006148
• UDI-Public: 10884523006148
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2019

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 Model Number: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/29/2019
• 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: Required Intervention