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

Model Number	EEAXL33
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/15/2019
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, the stapler fully fired and leak test was negative during a sigmoidectomy.The visual of the anastomoses also looked great inside and there were two full donuts however, the patient¿s anastomoses came apart and the abdomen was filled with feces 7 days post operatively.It was stated that the rectum was closed and an ileostomy was created.They had to clean the patient laparoscopically and the second surgery was extended to 5 hours.The patient had an open procedure and a wound vacuum was placed.The patient is still at the hospital.

• 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: 9160304
• Report Number: 2647580-2019-04977
• Device Sequence Number: 2459482
• Product Code: GDW
• UDI-Device Identifier: 20884523006176
• UDI-Public: 20884523006176
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2019

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: 12/31/2023
• Device Model Number: EEAXL33
• Device Catalogue Number: EEAXL33
• Device Lot Number: P9A1297KY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2019
• Initial Report FDA Received Date: 10/06/2019
• 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
• Patient Age: 58 YR