MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS FLEX ARTICNG LNR CUTR 45MM; STAPLE, IMPLANTABLE

Catalog Number ATS45

Device Problems Use of Device Problem (1670); Failure to Fire (2610); Noise, Audible (3273)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # p55a8h.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.(b)(4).Additional information received from the sales rep: i was told patient was fine and they used another stapler to finish the procedure after they released locked stapler.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.What were the indications for surgery? what type of procedure was being performed? were any clips used in the procedure? did the issue occur on the first firing of the device? if not, which firing? what color cartridge was being used? was the device straight or articulated? did the device cut? did the device deliver any staples? if yes, please describe the formation of the staples? what troubleshooting steps were taken to open the device? how was the device broken apart? how was the procedure completed? what is the current patient status? the analysis results found that the ats45 device was received with the firing mechanism damaged and with a reload loaded in the device.The reload was received fully loaded with staples with the lockout spring normal.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the firing trigger teeth were found broken.While no conclusion could be reached on what caused the firing mechanism to fail, it is possible that the device was attempted to fire on thicker tissue then indicated or attempted to fire through a locked reload in previous firings causing an increase of the internal forces resulting in the component yielding.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications; in addition, a sample of the batch is inspected at (b)(4).

Event Description

It was reported that during a laparoscopic nephrectomy procedure the device closed on a vessel, but would not fire or release.The customer called the sales rep and the sales rep was able to talk them through pushing the release button in back and prying the device open by hand.They attempted to staple across left renal hilium.The product made abnormal sound and would not come apart easily.Took one hour and three units of blood and a lot of anxiety to break it apart.A like device of the same product code was used to complete the procedure.

• Brand Name: ETS FLEX ARTICNG LNR CUTR 45MM
• 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: 6623131
• MDR Text Key: 77020861
• Report Number: 3005075853-2017-02955
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: ATS45
• Device Lot Number: P4RA1L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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): Required Intervention