MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 75MM SELECTABLE NEW TLC; STAPLE, IMPLANTABLE

Model Number NTLC75

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Event: unknown.Batch #t5dd0u.Device analysis: the analysis results found that the ntlc75 device was received with no apparent damage and with a cartridge reload present.The reload was received fully loaded with staples and with the swing tab in the locked position.The cartridge reload swing tab was reset in order to fire the cartridge.The device was tested for functionality with the returned reload and fired without any difficulties.However, the staple line at the distal end showed that some staples were malformed.The device was then tested with test reloads for functionality in the three (green, gold, blue) staple height selector positions and achieved its firing sequence without any difficulties.However, the staple line at the distal end showed that some staples were malformed when fired on the blue and green height selector positions.This condition is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and the proper loading technique.Although no conclusion could be reach on what caused the condition of malformed staples, it should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

Event Description

It was reported that during an unknown procedure, the firing force was higher than expected, and the device could not be fired.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 02/21/2020.Product complaint device was received for additional engineering analysis to confirm if malformed staples were caused due to misalignment between the cartridge channel and the anvil channel.The device was visually inspected, and no apparent damage was noted.The device was analyzed and misalignment between the cartridge channel and the anvil channel was observed when the device was closed.This condition has the potential to produce malformed staples.

• Brand Name: 75MM SELECTABLE NEW TLC
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9647211
• MDR Text Key: 204420734
• Report Number: 3005075853-2020-00601
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036002628
• UDI-Public: 10705036002628
• Combination Product (y/n): N
• PMA/PMN Number: K092577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NTLC75
• Device Catalogue Number: NTLC75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 02/19/2020
• Patient Sequence Number: 1
• Treatment: 75 MM NTLC SELECTABLE RELOAD