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

Catalog Number	SC60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p58g34.Investigation summary = > the analysis found that one sc60 device was returned with no apparent damage and with an ecr60b cartridge loaded on the device.The cartridge was received partially fired fired 1/16.After further analysis it was notice that the top of the one piece sled rails were deform.The device was tested for functionality with a test reload and it achieved a complete 3-strokes fire without any difficulties noted.The device fired, cut and formed all the staples as intended.The staple line was complete, and the staples were noted to have the proper b-form shape.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.The damaged on the sled, is consistent with high (outside indicated use) staple forming forces; however, there is insufficient evidence to determine the cause of the higher loads.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during an open sigmoidectomy, the device could not be fired at the first firing on the colon.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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: 7975875
• Report Number: 3005075853-2018-13676
• Device Sequence Number: 1382233
• Product Code: GDW
• UDI-Device Identifier: 10705036002703
• UDI-Public: 10705036002703
• 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
• Report Date (Section B): 08/28/2018

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: 10/02/2020
• Device Catalogue Number: SC60
• Device Lot Number: P94F19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1