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

Catalog Number NTLC75

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during an open colostomy closure, the firing knob did not move forward at the 2nd firing on the colon.Then, the firing knob was pushed forcibly, and it was broken off.No pieces were left inside the patient.The staple height was blue.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).Corrected data: pma/510k.

Manufacturer Narrative

(b)(4).Batch #: r59x3u.Investigation summary: 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 one reload present.The reload was returned with the proximal 36 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the locked position.No functional test could be performed with it due to the condition of the device.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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: 8664924
• MDR Text Key: 147088192
• Report Number: 3005075853-2019-19484
• 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,Followup
• Report Date: 05/23/2019

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: 08/04/2023
• Device Catalogue Number: NTLC75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 06/25/2019; 06/25/2019
• Supplement Dates FDA Received: 07/19/2019; 07/19/2019
• Patient Sequence Number: 1
• Treatment: 75 MM NTLC SELECTABLE RELOAD; 75 MM NTLC SELECTABLE RELOAD