MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GREEN RELOAD FOR ECHELON 60; STAPLE, IMPLANTABLE

Catalog Number ECR60G

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r58l5j.Investigation summary: upon visual inspection of three photos, the following was observed: the first and second photo show a green cartridge from top view and can be seen some staples inside of pockets.The third photo shows a green cartridge from top view and due to position and distance of photo could not be observed staples.In addition, the pan cartridge was noted partially dislodged from right side.Based on the photos reviewed, the event describe cannot be confirmed.The analysis results showed that one ecr60g cartridge reload was returned unfired with 9 double driver missing and 10 double driver loose, making the reload non-functional.In addition the cartridge pan was noted to be partially dislodged from right proximal side.No conclusion could be reached on what may have caused the cartridge pan to dislodge.In addition 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during the endoscopic stomach surgery, our customer noted the reload with no staple.Another device was used to complete the surgery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the analysis results showed that one ecr60g cartridge reload was returned unfired with 9 double driver missing and 10 double driver loose, making the reload non-functional.In addition the cartridge pan was noted to be partially dislodged from right proximal side.No conclusion could be reached on what may have caused the cartridge pan to dislodge.In addition 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.It should be noted that all devices are inspected 100% for staple presence by an automated vision system, and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: GREEN RELOAD FOR ECHELON 60
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8950969
• MDR Text Key: 199101668
• Report Number: 3005075853-2019-21605
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001782
• UDI-Public: 10705036001782
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: ECR60G
• Device Lot Number: R4103M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1