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

Catalog Number NTLC75

Device Problems Failure to Advance (2524); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p5824h.Month and day unknown.Only year (2018) is known.Device evaluation: the analysis results found that the ntlc75 device was received with the firing mechanism damaged as the firing knob was detached and the slip block assembly was noted to be damaged.The device was received with no reload loaded in the device.In addition, two reloads were received inside of a plastic bag.The sr75 reload (b) was received with the proximal one driver up without staple, and the remaining drivers down with staples present; the swing tab in the locked position.The sr75 reload (c) was received with the proximal 10 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the locked position.Due to the condition of the device, no functional test could be performed.The damage to the firing knob and slip block assembly is consistent with high (outside indicated use) staple forming forces; however, there is insufficient evidence to determine the cause of the higher loads.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.If enough force is applied the device could be damaged.For additional information please refer to the instructions for use.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 in the course of a right hemi-colectomy procedure using the device, an error occurred in the process of firing.The blade suddenly stopped in the middle of the device, and the blade didn't move forward.As an emergency measure, the surgeon backed off the firing knob and detach it from the tissue.A new cartridge was used for alternative, but the same issue was occurred.Eventually, the device(body) was changed to complete the procedure.There were no reported adverse consequences for the patient so far.

• Brand Name: 75MM SELECTABLE NEW TLC
• 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: 7759481
• MDR Text Key: 116600406
• Report Number: 3005075853-2018-11940
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036002625
• UDI-Public: 20705036002625
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2018

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: 09/06/2022
• Device Catalogue Number: NTLC75
• Device Lot Number: P4T43X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1