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

Model Number	TCR10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon used the tcr10 reload for a sub total gastrectomy procedure.Surgeon tried to fire the second reload for the resection.The gun got struck mid-way.Two reloads didn't complete the firing and had to use a third one.Surgery was delayed by 15-minutes.No fragments were generated.The surgery was successfully completed.
Additional Manufacturer Narrative
(b)(4).Batch #: 400a70.Additional information was requested, and the following was received: could you please clarify if there were any patient consequences? unknown.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? unknown.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 determined that the tcr10 reload was received with no apparent damaged and with the proximal 8 drivers up without staples and two staples were noted to be missing scattered along the staple line and the remaining drivers down with staples present.The returned reload had the swing tab in the unlocked position.The cartridge was tested for functionality with a test device and fired without any difficulties.The staple line was complete with the exception of the missing staples, and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.As it is possible that the firing knob was not returned to its home position while loading the reload.It is possible that an improper handling of the reload caused the staples to fell out, the proper handling instructions should be used when removing and reloading cartridges into the device, please reference the instructions for use.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3293480130
• MDR Report Key: 15294647
• Report Number: 3005075853-2022-05554
• Device Sequence Number: 15028654
• Product Code: GDW
• UDI-Device Identifier: 10705036003045
• UDI-Public: 10705036003045
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/25/2022

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: 08/31/2026
• Device Model Number: TCR10
• Device Catalogue Number: TCR10
• Device Lot Number: 459A79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown