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

Model Number ATS45

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #t5dp5v.The analysis results found that the ats45 device was received with no apparent damage and with a tr45w 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 staple line and cut line were complete and the staples met the staple form release criteria.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.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 lock out.Firing through the lockout mechanism will break the device.

Event Description

It was reported that during a lap left nephrectomy, an ets-flex 45 (ref ats45) was loaded properly with a 45 vascular reload (endopath ets45 2.5mm).When it was put into the abdomen, the surgeon adjusted the angle of the stapler to suit the window made for the renal vessels.The surgeon engaged the stapler with the first handle, he had it there for about five seconds before trying to engage the second handle.When he tried to squeeze the second handle, it would not advance and got stuck.The surgeon then decided to disengage the stapler and proceeded to use the echelon 45 stapler to successfully complete the procedure.There were 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: 10018351
• MDR Text Key: 190961558
• Report Number: 3005075853-2020-02469
• 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: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATS45
• Device Catalogue Number: ATS45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1