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

Model Number	TCT10
Medical Device Problem Codes	Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u5fc8e.(b)(4).Additional information was requested, and the following was received: did any pieces fall into the patient? no will all pieces be returned with the device? yes if no, were they discarded? yes did the device lock out and would not work? the knob you push to staple would not move forward.It worked on the firing before this, after the reload had broke.Device analysis: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the tct10 device was received with no apparent damaged and with a reload loaded in the device and a reload c present with its fork inside of a plastic bag.The reload b had the proximal 7 drivers up without staples, and the remaining drivers down with staples present.The returned reload b had the swing tab in the locked position.The reload c 117a97, was received unfired with the left fork broken off and with the swing tab broken-missing making the reload non functional.The reload b was reset and the device was tested for functionality with the returned reload and it fired, cut, and formed all the remaining staples as intended.The staple line and cut line were complete and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.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.The damage on the reload has consisted of an improper loading technique causing the damage to the swing tab and the forks not allowing the device to fire.Please reference the instruction for use for proper cartridge loading and more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a right colectomy procedure, reload of the device broke.Another reload was put in and the button to fire device would not move forward.A second like device was used to complete the case.There were no patient consequences reported.

• 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13368763
• Report Number: 3005075853-2022-00537
• Device Sequence Number: 11760392
• Product Code: GDW
• UDI-Device Identifier: 10705036003052
• UDI-Public: 10705036003052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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: 02/28/2026
• Device Model Number: TCT10
• Device Catalogue Number: TCT10
• Device Lot Number: V94M68
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown