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

Catalog Number NTLC75

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p5887g.Device analysis: 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 knife exposed, with the proximal 62 drivers up without staples and the remaining drivers down with staples present; the swing tab in the locked position.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.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.Additional information was requested and the following was obtained: when the firing knob was detached from the device, did it fall into the patient? if yes, was it removed? will it be returned with the device for analysis? if not, was it disposed of? the detached firing knob was collected.And, it will then be returned for analysis.

Event Description

It was reported that during a ileostomy closure procedure, the surgeon reported that the firing knob of the device was detached when the surgeon triggered the knob to fire.It was able to complete the firing process and the incident was happened during the firing of the second reload.There were no patient consequences reported.

• 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: 7475868
• MDR Text Key: 107197571
• Report Number: 3005075853-2018-09363
• 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: 04/08/2018

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
• Device Lot Number: P4T54D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Manufacturer Received: 04/08/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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