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 Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that during a laparoscopic right upper lobectomy, the knife did not move forward at the first firing on the pulmonary vein.The manual override lever did not move.Then the middle part and the distal end of the target tissue were ligated respectively and cut with a forceps in order to remove the device from the patient.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: 04/15/2020.D4: batch # t5ew5e.Device analysis: the analysis found that one pve35a 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 vasecr35 cartridge reload was received partially fired 1/10 and loaded in the device.The bailout system was reset and then, the returned device and cartridge reload were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.The device opened and closed without any difficulties noted.It is possible that while loading the reload, the cartridge was pushed farther back than the cartridge alignment stop windows resulting in the knife pushing the one piece sled forward and locking the cartridge.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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: 9860902
• MDR Text Key: 196127357
• Report Number: 3005075853-2020-01746
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

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: 11/30/2022
• Device Model Number: PVE35A
• Device Catalogue Number: PVE35A
• Device Lot Number: T95802
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/15/2020
• Patient Sequence Number: 1