MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP; STAPLE, IMPLANTABLE

Model Number PVE35A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: u5ac6g.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a lung transplantation, the knife stopped moving during the fourth firing.The manual override lever was used to return it.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 8/17/2020.Investigation summary: the analysis found that one pve35a device was returned with no apparent damage with one reload loaded in the device.The reload was received fully fired.The manual override door was 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.The bailout system was reset and tested for functionality in the straight position with a test reload, and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples met the staple release criteria.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformities were identified.The event described could not be confirmed as the device performed without any difficulties noted.The device opened and closed without any difficulties noted.

• Brand Name: ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10296336
• MDR Text Key: 200205822
• Report Number: 3005075853-2020-03670
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014584
• UDI-Public: 10705036014584
• Combination Product (y/n): N
• PMA/PMN Number: K141952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVE35A
• Device Catalogue Number: PVE35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 07/20/2020
• Patient Sequence Number: 1