MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM; STAPLE, IMPLANTABLE

Catalog Number ATW35

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/25/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.Additional information received: the account contact indicated there is still no word as to whether the device was a contributing factor in the outcome and that the investigation results from the coroner may take several months.He indicated that while no formal information has been shared to date, there have been informal conversations which suggest there was no device involvement in this outcome.The sales manager spoke with the surgeon, the patient who died was a kidney donor.

Event Description

It was reported that a patient did not survive an unknown procedure.One device and two reloads were used in the procedure.The hospital is retaining the devices at this time and will be sending them to a third party for assessment.Once their assessment is complete, they made be released.They have no further information that they can share at this time.

Manufacturer Narrative

(b)(4).Additional information received: spoke with the engineer appointed by the coroner to perform analysis of the device.He indicated he was provided with the device and two spent cartridges as well as sample cartridges for his testing.He was advised that the cartridge batch number for the cartridge fired when the difficulty was encountered is m53r96.He has test fired the subject device two times at another hospital.The first firing was across a surgical glove and the device fired and formed staples as expected according to mr.(b)(6).The second firing was across heat shrink tubing and he included a type of gold wire to simulate a firing across an object thicker than a vessel and "unclosed" staples were delivered.He indicated his hypothesis is that there may have been thicker tissue included within the jaws of the device at the time of firing which caused bleeding and unformed staples.The engineer indicated there is a video of the procedure which is in the possession of the coroner and he read excerpts from the coroner's report.The report describes a well formed staple line across the renal artery stump and 5 open unformed staples on the renal vein with unformed staples also located in para aortic soft tissue at the leven and above the celiac trunk ostium.The report also describes two rows of "engaged clenched staples over a small portion (apparent muscle tissue) adjacent to the celiac trunk.The engineer is inquiring whether it's possible to discern/confirm staples were delivered from the cartridge.I advised that i would speak with the engineers and get back to him.The engineer advised that he sees the vision system mark and the recycled mark on the cartridge from batch m53r96.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5326896
• MDR Text Key: 34349016
• Report Number: 3005075853-2015-08321
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020779
• 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,Followup,Followup,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: ATW35
• Device Lot Number: M9333P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1