MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE LINEAR STAPLER; STAPLE, IMPLANTABLE

Catalog Number TX30V

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Death (1802); Exsanguination (1841); Blood Loss (2597)

Event Date 04/25/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Batch # m55g9h.Additional information was requested and the following was obtained: linear stapler was attached to a stronger vessel, closed, shot down.Once opened, vessel was not stapled but cut.Massive hemorrhage, which has been trying to stop.The patient became a heart attack or atrial fibrillation.Heart specialists were called, without success.Retrospectively, they became known that the patient was cardiac.What were the indications for surgery? lung cancer (left upper lobe).Did the issue occur on the first firing? if not how many times was the device reloaded? yes.The device was never reloaded at all.After the device was closed was the device cut with a scalpel? no.Was there any precaution taken to provide proximal and distal control prior to stapling/cutting? yes.Following our standard procedure two threads were passed around the lower circumference of the vessel exposed for suturing ¿ one thread guided towards the periphery, one towards the central part of the artery.Both threads immediately came loose when the continuity of the vessel was destroyed after the staples had been fired.If the device was fired, were staples present and what was their form? please describe.Not possible.There was a profuse bleeding directing our focus elsewhere.What an autopsy conducted and, if so, are the results available? yes.The results have not been communicated to us.Is the surgeon willing to speak with the ethicon medical director and engineering? there is a multilingual director available to speak with surgeon.Contact the surgeon directly.The analysis results showed that the tx30v device arrived in good visual condition and with a reload loaded on the device.The reload was received fully loaded with staples.The device was tested for functionality with the returned reload and it fired and formed all the staples as intended.The device fired without any difficulties, the staples were noted to have a proper b-formation and the staple line was complete.A batch record review was performed and no anomalies were found during the manufacturing process.

Event Description

It was reported that during the suturing of a large (approx.8mm in diameter) pulmonary artery branch to the lingula procedure, "when settle the pulmonary artery," the staples have cut the vessel.Blood flow could not be stopped.The patient died on the operating table.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the device was returned with a cartridge full of staples and no evidence of firing.When was the bleeding identified: after firing the device; upon closure, upon attempted firing or upon opening: upon opening; does the surgeon use multiple brands and what is his/her experience with the device: surgeon is a senior professor, has more than 20 years of experience with all types of brands; does the surgeon typically open and inspect the staple line prior to transection: yes; as this device does not have a knife, why does the surgeon believe the device cut: the surgeon never thought that the device would cut.Nevertheless there was immediate severe bleeding upon opening the device after firing ¿ somehow the vessel had been neatly severed.

Manufacturer Narrative

(b)(4).Additional device analysis performed: the analysis found that the device worked as intended during the test on the pig pulmonary artery and there was no tearing or severing of the artery.

Manufacturer Narrative

Pi1-11dj7wn / (b)(4).Date sent: 1/23/2024.This report is being submitted per the request of fda to correct sequential numbering for the mdr follow up report originally submitted.

• Brand Name: PROXIMATE LINEAR STAPLER
• 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: 5643416
• MDR Text Key: 44829380
• Report Number: 3005075853-2016-02617
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: TX30V
• Device Lot Number: M4J585
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death