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

Catalog Number PVE35A

Device Problem Defective Component (2292)

Patient Problem Blood Loss (2597)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date sent: 9/25/2019.Event date unk.Batch # unk.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.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.Additional information requested and received: what was the surgical procedure? pneumonectomy.What was the approximate width of compressed vessel? the vessel was inside the cut line, he doesn¿t know the width.Was the vessel being stapled the main pulmonary artery or a branch? main pulmonary artery.Can it be confirmed that the entire width of compressed vessel was proximal to cut line? yes.Can it be confirmed that there was no extraneous tissue within jaws distal to cut line? yes.Were the tips of device visible during firing? yes.Does the surgeon wait 15 seconds prior to firing? yes.How was the issue addressed? clamp, clip, suture, blood transfusion.Were there any staple formation issues noted throughout the care of patient? there were some staples in the surgical fields but they don¿t remember if they were correctly formed or not.What is the current patient status? he¿s fine.

Event Description

It was reported that the pvs stapler failed on pulmonary artery.After firing and opening stapler, the vessel started bleeding.Patient needed massive blood transfusion.

• 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: 9120445
• MDR Text Key: 162639008
• Report Number: 3005075853-2019-22336
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PVE35A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention