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

Model Number ATS45

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u5ay4k.Investigation summary: the analysis results found that the ats45 device was received with the firing mechanism damaged and two tr45w cartridges loaded in the device.The reload (b) was received unfired.The reload (c) was received partially fired 1/10 with the reload lock out spring damaged.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.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/ batch.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% inspection 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 appendectomy, on the second firing, a 'crack' was heard and the device locked out.There was no difficulty opening the device and the first firing went fine.A similar device was used to complete the case with no patient consequences.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10289167
• MDR Text Key: 199995317
• Report Number: 3005075853-2020-03627
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATS45
• Device Catalogue Number: ATS45
• Device Lot Number: U93V4M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1