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 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r58n5z.Investigation summary
=
> the analysis results found that the ats45 device a was received with no apparent damaged and with a 6r45b cartridge loaded on the device.The returned reload was partially fired 1/10.The returned device was tested for functionality with a test reload and it fired, cut, and all the staples formed as intended.The device fired without any difficulties, the staple line was complete, and the staples were noted to have the proper b-formed shape.The condition of the reload indicates that the device's firing cycle was interrupted.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.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 with the same outcome.Another 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: 7952158
• MDR Text Key: 123371960
• Report Number: 3005075853-2018-13426
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001072
• UDI-Public: 10705036001072
• 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: 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