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

Model Number	EEAXL33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	10/03/2018
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, while on colon during a laparoscopic low anterior resection, the size may have been too large and tore the tissue.When it was extracted from the patient, the staple line seemed intact.They tried to over sew but tissue was bad.Eventually, they removed the anastomosis and redid with the same device which was smaller in diameter to complete the case.The surgical time was extended by more than 30 minutes due to the product problem.
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
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: 8016157
• Report Number: 2647580-2018-05186
• Device Sequence Number: 19158261
• Product Code: GDW
• UDI-Device Identifier: 10884523006179
• UDI-Public: 10884523006179
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018

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 Expiration Date: 01/31/2023
• Device Model Number: EEAXL33
• Device Catalogue Number: EEAXL33
• Device Lot Number: P8A0659KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 11/19/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 10/30/2018; 12/11/2018
• 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: Required Intervention