MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RELOAD VASC LIN CUTT; STAPLE, IMPLANTABLE

Catalog Number	TVR55
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 3/6/2025, d4 batch #975c64.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample revealed that one tvr55 reload was received unfired, with the swing tab in the unlocked position and upon visual inspections scratches and damage was noted on the cartridge deck.No further functional test was performed due to the condition of the reload.The damage to the reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife during device firing, prior to reloading the device, clean in sterile solution and then wipe the anvil and reload channel to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Please reference the instruction for use for more information.In order to replicate the reported event, the reload was loaded into the channel of a test device and it was loaded without difficulty.The event described could not be confirmed as the reload was loaded without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: the reload cannot be inserted unless the firing knob is in its original position.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 975c64, 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 filed as appropriate.
Event or Problem Description
It was reported that during a robot assisted gastrectomy, the cartridge could not be inserted when tried to insert the cartridge at the 2nd firing.It was used on duodenum.Another cartridge was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 21538226
• Report Number: 3005075853-2025-01837
• Device Sequence Number: 7000241
• Product Code: GDW
• UDI-Device Identifier: 10705036013396
• UDI-Public: (01)10705036013396(17)290530(10)975C64(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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 Catalogue Number: TVR55
• Device Lot Number: 975C64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown