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

Model Number NTLC75

Device Problems Difficult to Insert (1316); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported: procedure: unknown.3 firings in total.1st firing was on small bowel 10cm from rectum.2nd firing for anastomosis.3rd firing to close the anastomosis.After the 2nd firing, 2nd hcp saw the nurse struggling to setup the ntlc and he went to load it for the 3rd firing.The stapler was then passed to 1st hcp.During firing, everything seems normal.(closing of handle is easy - tissue not very thick.Forward and backward movement of the firing knob is smooth.) after firing, when 1st hcp opened the 2 handles apart, she spotted the knife left at the distal end of the ntlc75 not retracted back.There were no patient consequences.

Manufacturer Narrative

(b)(4).Only event year known: 2022.Batch # unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Per photographic evaluation: this is an analysis of a photo submitted to ethicon endo surgery for evaluation.During the visual analysis, the following was observed: the photo shows a portion of the device from the channel area with a black reload loaded and the knife can be seen exposed.Also, all drivers are up.The condition of the knife exposed 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 is being used.Based on the photo the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: 75MM SELECTABLE NEW TLC
• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 13952357
• MDR Text Key: 288317524
• Report Number: 3005075853-2022-01913
• 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: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• 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?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SR75