MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 60 ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Catalog Number	EC60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #r5989v.Investigation summary: the analysis results found that one ec60 device was returned with no apparent damage and with a gst60w cartridge not loaded on the device.The reload was received partially fired 1/16 with the pan detached from the cartridge.The device was tested for functionality with a test cartridge reload and achieved its complete 3-stroke firing sequence without any difficulties.The staple line and cut line were complete and the staples meets the staple release criteria.Batch records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It is possible that while loading the reload, the cartridge was pushed farther back than the cartridge alignment stop windows resulting in the knife pushing the one piece sled forward and locking the cartridge.It is also possible that handling by the customer could dislodge the pan.Dislodging as a result of the removal of the cartridge from the device is the most likely scenario.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.
Event or Problem Description
It was reported that during the laparoscopic gastrectomy surgery, the device would not fire when severing duodenum tissue on the 1st firing.Changed to a new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9555266
• Report Number: 3005075853-2020-00091
• Device Sequence Number: 3172131
• Product Code: GDW
• UDI-Device Identifier: 10705036001690
• UDI-Public: 10705036001690
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2019

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: 07/14/2021
• Device Catalogue Number: EC60
• Device Lot Number: R94692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1