MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 440MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PLEE60A

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.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.As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported that during a laparoscopic sleeve gastrectomy, while using seam guard the device would not pass through the trocar easily."it appeared that the anvil was bent and the distal tip would not come together".The procedure was completed with this device and there were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # r5a98g.Investigation summary: the analysis results found that one plee60a device was returned with the anvil bent upwards and with a gst60g reload loaded on the device.The reload was received fully fired.No functional test was performed due the condition.It is possible that the device was clamped over an excess of tissue causing the anvil to bend and for the firing stroke and the staple form to be incomplete.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected at fgqa.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: POWERED 60 ECHELON +, 440MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8179710
• MDR Text Key: 131035352
• Report Number: 3005075853-2018-15266
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014614
• UDI-Public: 10705036014614
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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: 09/08/2021
• Device Catalogue Number: PLEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/10/2019
• Patient Sequence Number: 1