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

Model Number	EC60
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during the open colon surgery , when severing transverse colon tissue on the 1st firing, after fired, noted staples malformed with irregular shape.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/22/2020.D4: batch # r5989v.H6: component code: safety(g06).Investigation summary: the ec60 device was received for analysis with no visual non-conformances and with an ecr60b cartridge loaded on the device.The reload was received partially fired 1/16.The device was tested for functionality with the returned reload by resetting and reloading it into the device.The staple line and cut line were complete and the remaining staples meet the staple form release criteria, and the instrument achieved its complete 3-stroke firing sequence without any difficulties.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.It is possible that while loading the reload, the reload was pushed farther back than the cartridge alignment stop windows resulting in the knife pushing the one piece sled forward and locking the cartridge.Please reference the instruction for use for more information.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.

• 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: 10909285
• Report Number: 3005075853-2020-06270
• Device Sequence Number: 3317209
• Product Code: GDW
• UDI-Device Identifier: 10705036001690
• UDI-Public: 10705036001690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 07/31/2023
• Device Model Number: EC60
• Device Catalogue Number: EC60
• Device Lot Number: R94692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1