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

Model Number PVE35A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #.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.The manufacturing record evaluation was performed, and the manufacturing criteria was met prior to the release of this batch/lot.Additional information requested and received: what was the procedure? lap hemihepatectomy.Was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? yes, malformed staples ¿ open legs and still in u formation.How was the bleeding controlled? clamped.How much blood was lost (ml)? unknown.Did the patient require a transfusion? no.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) no, bleeding was controlled in timely manner.Patient's current condition if known? unknown surgeon on leave.

Event Description

It was reported that the stapler would not function.After issue occurred, the patient suffered a significant bleed.Another device needed to opened.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent: 1/23/2020.D4: batch # r5ah1x.Investigation summary: 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 meets the staple release criteria.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.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: 9109416
• MDR Text Key: 203521835
• Report Number: 3005075853-2019-22292
• 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: 08/28/2019

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: 09/23/2021
• Device Model Number: PVE35A
• Device Catalogue Number: PVE35A
• Device Lot Number: R95136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/23/2020
• Patient Sequence Number: 1