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

Catalog Number	ECR60T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	01/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ¿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 Manufacturer Narrative
(b)(4).Date sent: 6/16/2022.Batch # unk.This event was reported by the patient via the maude database.Based on the information provided, it could not be concluded if the post-operative complication experienced by the patient was related to patient factors or the use of the ethicon device, other devices, (non-ethicon), that were also utilized during the procedure.Additionally, no clarifying questions could be asked as no follow-up contact information was provided with the report.As such, correlation between the ethicon device use and the postoperative patient complication cannot be ascertained.Should additional information be obtained later, the file will be reassessed to determine if any updates are warranted.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lo, and no non-conformances / manufacturing irregularities were identified.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/14/2023 upon review it was identified that this is a duplicate report.All reported information for this event was reported under 3005075853-2022-03861.Moving forward all additional information will be filed under 3005075853-2021-06369.

• 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 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14712010
• Report Number: 3005075853-2022-03861
• Device Sequence Number: 2176543
• 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
• Report Date (Section B): 08/14/2023

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 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: 05/31/2022
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/14/2023
• 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