MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 340MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PSEE60A

Device Problems Defective Component (2292); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts have been made to obtain the following additional information: can you please provide more event details how staples were partially deployed and how the device was removed from the tissue? did the device partially fire (start to deploy staples and cut but could not be completed)? if yes, were the staples in the tissue formed in the proper closed b-formation? how was the device removed off of the tissue? was the knife reverse switch attempted? if yes, did the knife reverse switch function as designed? did the jaws of the device eventually open? to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a laparoscopic appendectomy, the device was fired, and the staples were partially deployed.The override button was tried, and it did not work.The device was removed, and in the process, tissue was torn.The procedure was completed with a competitive device.There was no patient consequence reported.

Manufacturer Narrative

Product complaint # (b)(4).User facility medwatch # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Batch # r5aj9z.Investigation summary: the analysis found that one psee60a device was returned with no apparent damage and with the manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.A gst45b cartridge reload was received unfired and loaded in the device.The bailout system was reset and then, it was tested for functionality in the straight position with a test cartridge reload and achieved its complete firing sequence without any difficulties.The staple line was complete, and the staples meet the staple form release criteria.It should be noted that a 60mm device is designed to work only with 60mm cartridges, for further loading instructions please refer to the echelon flex 60 powered ifu.The device opened and closed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: POWERED 60 ECHELON +, 340MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8814063
• MDR Text Key: 152031969
• Report Number: 3005075853-2019-20637
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: 10705036014607
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2019

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: 09/26/2021
• Device Catalogue Number: PSEE60A
• Device Lot Number: R94X4A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/26/2019; 09/09/2019
• Supplement Dates FDA Received: 08/22/2019; 09/30/2019
• Patient Sequence Number: 1