MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR CUTTER THICK; STAPLE, IMPLANTABLE

Model Number	TCT75
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the unknown surgery, could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Batch # 501a10.Per photographic evaluation: this is an analysis of five photos submitted for evaluation.During the visual analysis, the following was observed: the photo shows a device with a reload loaded from the top view and some staples can be seen protruding.The second photo shows a device from the anvil and channel area with a reload loaded and some staples can be seen protruding.The third photo shows a label on a box of product code tct75 and lot # 513a58.The four photo shows a device with halves separated and the channel shroud can be seen with a reload loaded.It shows 4 drivers up and after that two protruding staples were noted.It should be noted that the reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.In addition, failure to complete the stroke may result in an incomplete staple line.The fifth photo shows a device with halves separated and the anvil shroud can be seen with no apparent damage.Based on the photos the event described is confirmed, however, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the tct75 device was received with the anvil shroud detached and with a reload loaded in the device.The reload had the proximal 6 drivers up without staples, and the remaining drivers down with staples present.The returned reload had the swing tab in the locked position and it was noted the right gripping surface and the cartridge deck damaged making the reload nonfunctional.The device was tested for functionality with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete, and the staples meet the staple form release criteria.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The damage to the cartridge deck is consistent with the device being clamped over a hard object.The condition of the gripping surface damaged 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 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.In addition, failure to complete the stroke may result in incomplete staple line.While no conclusion could be reached as to how the damage to the device occurred, it is possible that the damage was due to improper handling of the device.Please reference the instruction for use for more information.A manufacturing record evaluation was performed for the finished device batch number 501a10, and no non-conformances were identified.

• Common Device Name: 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16023108
• Report Number: 3005075853-2022-08865
• Device Sequence Number: 14923657
• Product Code: GDW
• UDI-Device Identifier: 10705036013150
• UDI-Public: 10705036013150
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2026
• Device Model Number: TCT75
• Device Catalogue Number: TCT75
• Device Lot Number: 513A58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown