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

Catalog Number ATS45

Device Problems Failure to Advance (2524); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r58n5z.Investigation summary
=
> the analysis results found that the ats45 device was received with the firing mechanism damaged and with a tr45w cartridge loaded in the device.The reload was received partially fired 1/10 and with the reload lock out spring damaged.In addition cartridge b, 6r45b, batch r58u4r, was received, fully fired, with the lockout 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.The damage to the reload lockout spring is consistent with damage observed when the firing cycle is started, interrupted, released, and restarted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.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 fgqa.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a laparoscopic appendectomy procedure that the staff loaded the device the surgeon attempted to fire but the device locked out.A few of the staples deployed but the knife blade did not advance through any tissue.The device was removed, and a second device was opened.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: ETS FLEX ARTICNG LNR CUTR 45MM
• 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: 7951620
• MDR Text Key: 123374085
• Report Number: 3005075853-2018-13415
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001072
• UDI-Public: 10705036001072
• Combination Product (y/n): N
• 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: 08/21/2018

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: 05/31/2023
• Device Catalogue Number: ATS45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1