MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GRAY RELOAD FOR 45MM ECHELON; STAPLE, IMPLANTABLE

Model Number	ECR45M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during an unknown procedure, after firing, some staples formed with irregular shapes and the anastomotic site was oozing.Another two reloads had the same issue.Oozing was stopped with compression hemostasis.There was no patient consequence reported.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/26/2020.One photo received.Upon visual inspection of one photo, the following was observed: the photo shows tissue with what appears to be clips supporting the tissue.No bleeding or malformed staples could be observed.Based on the photo alone the event describe cannot be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

• Brand Name: GRAY RELOAD FOR 45MM ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10443497
• Report Number: 3005075853-2020-04275
• Device Sequence Number: 14051241
• Product Code: GDW
• UDI-Device Identifier: 10705036001751
• UDI-Public: 10705036001751
• Combination Product (Y/N): N
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: 08/31/2024
• Device Model Number: ECR45M
• Device Catalogue Number: ECR45M
• Device Lot Number: T40V72
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/26/2020
• Patient Sequence Number: 1