MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETHICON ENDO-SURGERY, LLC LINEAR CUTTER FOR USE WITH SELECTABLE RELOAD, 75 MM; STAPLE, IMPLANTABLE

Catalog Number NTLC75

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2018.Batch # p5887g.Device analysis: the analysis results found that the ntlc75 device was received with the firing mechanism nonfunctional as the firing knob was detached and the slip block assembly was noted to be damaged.The device was received with a reload loaded in the device.The reload was returned fully loaded with staples and with the swing tab in the unlocked position.In addition, a knife was received inside of a plastic jar and a pan was present with batch number p5890y.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during duodenum transaction in a whipple case, the blade stopped and could not proceed, so surgeon changed another device and could finish the operation.There was no reported patient consequence.

• Brand Name: ETHICON ENDO-SURGERY, LLC LINEAR CUTTER FOR USE WITH SELECTABLE RELOAD, 75 MM
• 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: 8531105
• MDR Text Key: 142535907
• Report Number: 3005075853-2019-18225
• 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: 10/12/2018

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: 09/18/2022
• Device Catalogue Number: NTLC75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RELOAD - SR75