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

Catalog Number PVE35A

Device Problems Defective Component (2292); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.When the device failed to staple, did it cut the tissue?.

Event Description

It was reported that during a thoracotomy procedure the device made a funny noise on the first firing attempt across the pulmonary vessel.The tried to use the reverse button which did not work.They manually opened the device and it was noticed that although no staples deployed all of the drivers were up.The procedure was completed using a like device.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 8/21/2018.Batch # r5772d.The analysis found that one pve35a device was returned with no apparent damage and with one cartridge reload loaded on the device.The reload was received fully fired.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.The knife reverse button worked properly during testing.The device opened and closed without any difficulties noted.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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7704599
• MDR Text Key: 114707257
• Report Number: 3005075853-2018-11425
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036014581
• UDI-Public: 20705036014581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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: No Information
• Device Expiration Date: 12/24/2020
• Device Catalogue Number: PVE35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1