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

Model Number	ECR60M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # :unk.Report source: mw5091021.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested, and the following was obtained: how much blood was lost (ml)? unknown did the patient require a transfusion? no was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) no.
Event or Problem Description
It was reported that during an unknown procedure, ¿md had used several gray echelon staple reloads with the powered echelon 60 stapler.When she used the 5th gray reload, that was from a different lot number for the 4 previous, it malfunctioned.The stapler fired normally, but the staple line was not sealed fully with staples.Md had to quickly use several hemo-clips on the vessels that were spraying blood.This could have been a very serious complication had she not been able to react quickly.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent: 01/24/2020.D4: batch # t5d37u.Device evaluation summary: the analysis results showed that one ecr60m cartridge reload was received.The reload was received with no apparent damage and fully fired.As the returned reload was received fully fired, no functional test could be performed due to the condition of the reload.Event described could not be confirmed as the cartridge was received fully fired.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: GRAY RELOAD FOR 60MM ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9505550
• Report Number: 3005075853-2019-24659
• Device Sequence Number: 16929427
• Product Code: GDW
• UDI-Device Identifier: 10705036013792
• UDI-Public: 10705036013792
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2024
• Device Model Number: ECR60M
• Device Catalogue Number: ECR60M
• Device Lot Number: T40P9Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1