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

Catalog Number SC60A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r5932w investigation summary the sc60a device was received for analysis with no apparent damaged and with two ecr60m cartridge reloads present.The cartridge reload (b) was received partially fired 1/3.The cartridge reload (c) was received partially fired 1/3 and with damage on cartridge deck.The device was tested for functionality in the articulated position with the returned cartridge reload (b) by resetting and reloading it into the device.The device achieved its complete stroke firing sequence without any difficulties.The remaining staple line and cut line were complete and the staples were noted to have the proper b-form shape.The partially fired is consistent with an incomplete or interrupted cycle.The found damage on the deck is consistent when the device is fired over an already existing staple line; when this happens the knife plows the staples on cartridge deck and shaving may occurs.In order to verify the condition of the internal components of the reload it was disassembled and no anomalies were noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a lap appendectomy, the stapler the knife blade just would only advance one half of the way down the cartridge.They couldn't get the knife blade to advance all the way down to the distal end of the cartridge.They pulled another reload and the same issue occurred.Case completed with clip applier.There were no patient consequences reported.

• Brand Name: ECHELON FLEX 60 COMPACT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8091743
• MDR Text Key: 128038177
• Report Number: 3005075853-2018-14505
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036002710
• UDI-Public: 10705036002710
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Catalogue Number: SC60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1