MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 LONG; STAPLE, IMPLANTABLE

Model Number	EC45AL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient evolved with important digestive hemorrhage.Readmitted for evaluation, requiring blood transfusion.
Additional Manufacturer Narrative
(b)(4).Batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What were the indications for the primary surgical procedure? please provide details as to what is meant by ¿gastroplasty".How was the post operative hemorrhage identified? was the site of the hemorrhage identified? was there any difficulties with the device intraoperatively? was there any additional medical or surgical interventions required other than the blood transfusion? could you please provide a timeline of events from primary procedure to post op bleed? 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 lot/batch number, 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.

• Brand Name: ECHELON FLEX 45 LONG
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15429526
• Report Number: 3005075853-2022-06145
• Device Sequence Number: 4680049
• Product Code: GDW
• UDI-Device Identifier: 10705036001683
• UDI-Public: 10705036001683
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: EC45AL
• Device Catalogue Number: EC45AL
• Device Lot Number: V94N69
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECR45B; ECR45W
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male