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	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # (b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.
Event or Problem Description
It was reported that the staples malformed after firing.During the vats lobectomy, after fired with ecr60b, when severing the lobe of lung, found the staples malformed.Another device was used to complete the surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch # p55m2e.Device evaluation: the analysis results found that one sc60 device was returned with no apparent damage and with no cartridge reload present.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 were noted to have the proper b-form shape.The event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 7454672
• Report Number: 3005075853-2018-09291
• Device Sequence Number: 1417101
• Product Code: GDW
• UDI-Device Identifier: 20705036002700
• UDI-Public: 20705036002700
• 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): 03/28/2018

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: 02/14/2022
• Device Catalogue Number: SC60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1