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

Catalog Number PVE35A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Month and day unknown.Only year (2018) is known.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.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.

Event Description

It was reported that during a lobectomy, professor fired the device and the blade didn't advance completely to the end of the jaw (it stopped in the middle).As it was vessel inside the jaw, professor carefully reversed the knife and changed reload.There were no patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Batch number: r57h6e.Investigation summary: the analysis found that one pve35a device was returned with no apparent damage and with no cartridge loaded on the device.The device 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 and cut line were complete and the staples were noted to have the proper b-form shape.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 7866325
• MDR Text Key: 120104146
• Report Number: 3005075853-2018-12623
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036014581
• UDI-Public: 20705036014581
• 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: 08/16/2018

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: 01/20/2021
• Device Catalogue Number: PVE35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RELOAD - VASECR35