MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOAD FOR 60MM ECHELON; STAPLE, IMPLANTABLE

Catalog Number	ECR60T
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cancer (3262); Insufficient Information (4580)
Date of Event	01/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had surgery in 2016.She was inquiring about ecr60t which was used in her surgery and wanted to know which lot number she has implanted in her.Patient states that she has since had to have her stomach removed and is very sick.Patient states that she is a single mom, has cancer and is very sick.
Additional Manufacturer Narrative
(b)(4).Medical device: batch # unk.Date of event: unknown; captured as awareness date.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.Additional information was received: spoke with patient last week who initially indicated she was unwilling to provide any additional detail.She eventually shared that the hospital was (b)(6) regional medical center and that they are no longer in business and had no detailed information.Her surgeon was (b)(6) md and the surgery was in (b)(6) 2016.Explained the supply chain process and hipaa requirements and why the lot number for any device used in her surgery would need to come from the hospital or possibly the third party distributor, (b)(4).A phone number for (b)(4) was provided and she was planning to follow up with them directly.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/4/2021.Additional information: per the patient: harmed by ethicon echelon stapler black ecr60t.Stomach removed after leak could not be stopped.Lung removed and spleen.Now i have leukemia.Because of the stapler.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.See attached op report.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.See attached op report.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.See op report.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.See attached op report.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.See attached op report.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.See attached op report.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/11/2023.Additional information was obtained: "i had endoscopic gastric sleeve surgery.Surgeon used ethicon echelon endocutter black model ecr60t.I had staple line leak and ended up having three organs removed and now have leukemia.I didn't know the product was on a fds recall.¿ additional information was obtained: unknow individual requesting help and indicating they had been harmed by the product cleared in k131663.Individual sending email included a phone number: ((b)(6)and an email address: (b)(6), and a pdf of clearance k131663.Full message reads: subject: please help hi there.I was harmed by this medical device.I need the lot number.Can you help? thank you (b)(6).

• Brand Name: RELOAD FOR 60MM ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12683579
• Report Number: 3005075853-2021-06369
• Device Sequence Number: 3707028
• Product Code: GDW
• UDI-Device Identifier: 10705036014362
• UDI-Public: 10705036014362
• Combination Product (Y/N): N
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/11/2023

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: 03/31/2014
• Device Catalogue Number: ECR60T
• Device Lot Number: K4CG8P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 01/06/2023; 01/06/2023; 01/06/2023; 01/06/2023; 01/06/2023; 01/06/2023; 08/14/2023
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/06/2021; 01/06/2023; 01/06/2023; 01/06/2023; 01/06/2023; 01/06/2023; 01/06/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown