MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LINEAR CUTTERS NTLC; STAPLE, IMPLANTABLE

Catalog Number NTLC75

Device Problems Break (1069); Mechanical Problem (1384); Sticking (1597)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191); Insufficient Information (4580)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.As a lot/batch was not provided, a device history could not be performed.Additional information was requested and the following was obtained: did any pieces fall into the patient? no.

Event Description

It was reported by the sales rep that during a semi-open surgery, the device was locked out and the knife did not move forward at the first firing of feea on ileum and jejunum.The cartridge was replaced and the firing force became higher than expected at the second firing and the firing knob broke off.The staple height was blue and the knife stopped at the same place for both firings.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Upon review of the additional information received, the file has been changed to a serious injury.Additional information was requested and the following was obtained: what were the indications for surgery? no information from the hospital.What tissue was the device fired on during the second and third firing? the device was used for the functional end to end.The device was used for closing the anastomosis site on the second and third firing.On what area of the structure (intestine) did the first firing occur? no information from the hospital.On what area of the structure (intestine) did the second firing occur? no information from the hospital.On what area of the structure (intestine) did the third firing occur? no information from the hospital.Was a leak test performed before closing the patient? no information from the hospital.What is the current patient status? the patient was stable.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 one reload present.The reload was returned with the proximal 27 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the unlocked position.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.Please refer instructions for use.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.Due to the condition of the device, no functional test could be performed with it due to the condition of 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

Updated event description: it was reported that during an "feea" of ileum and jejunum, the 1st firing was completed properly, but at the 2nd firing with another device, the knife stopped on the way.The cartridge was replaced, and then the knife stopped again and the firing knob broke off on the way of the 3rd firing.The staple height was blue.Another third device was used for the 4th firing to complete the case.Leak was confirmed after the operation.The doctor commented that the misfired lines of the 2nd and the 3rd firings should have been cut before the 4th firing, and the leak was likely from where the lines are overlapping.Re-operation was performed since panperitonitis was developed, and additional hand suture was performed on the leaking site.The condition of the patient has been stable since the reoperation.

Manufacturer Narrative

(b)(4).This correction is being submitted to correct the sequential numbering for the follow up reports.Follow up report # 4 submitted should have been submitted as follow up report #2.There is not a follow up #3 or #4.

Manufacturer Narrative

(b)(4).Date sent: 7/26/2017.H11: corrected data: f10 patient: 3191 and h3 evaluation summary 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 one reload present.The reload was returned with the proximal 27 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the unlocked position, it is possible that the swing tab was manipulated with before sending the cartridge over, resulting in the unlocked swing tab.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.Due to the condition of the device, no functional test could be performed with it due to the condition of 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.

Manufacturer Narrative

(b)(4).Date sent: 1-18-2024.This report is being submitted per the request of fda to correct sequential numbering for the mdr follow up report originally submitted.This is follow up report #3.

• Brand Name: LINEAR CUTTERS NTLC
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6622875
• MDR Text Key: 77298305
• Report Number: 3005075853-2017-02953
• Device Sequence Number: 1
• Product Code: GDW
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Catalogue Number: NTLC75
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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
• Patient Outcome(s): Required Intervention