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

Catalog Number	TX60G
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 5/13/2025.D4 batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: were there missing staples from the staple line? if the device deployed staples, what was the appearance of the staples (b-formation, irregular, legs straight)? could you please clarify if there were any patient consequences? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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 an unknown procedure when using the device, the stapler does not want to staple parts of the colon.Consequently, using another device of the same reference, the procedure could be successfully completed.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/15/2025.Additional information was requested, and the following was obtained: 1.Were there missing staples from the staple line? no.2.If the device deployed staples, what was the appearance of the staples (b-formation, irregular, legs straight)? 3.Could you please clarify if there were any patient consequences? lengthening of the operating time about 15 minutes.4.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event?.
Additional Manufacturer Narrative
(b)(4).Date sent 6/4/2025.D4 batch #148d27.Corrected data d4: udi#.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 tx60g device arrived with no apparent damage and with a reload loaded on the device.The reload was received with only 12 staples present and protruding.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria.It should be noted that when manipulating the device only the closing trigger should be grasp until ready to fire the device.Do not grasp the firing trigger before the device is to be fired.If the firing trigger is manipulated it could cause the staples to deploy partially or completely resulting in malformed staples and a premature lockout situation.Please reference the instruction for use for more information.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.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 148d27, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent 5/30/2025.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22008422
• Report Number: 3005075853-2025-03562
• Device Sequence Number: 14750568
• Product Code: GDW
• UDI-Device Identifier: 10705036003359
• UDI-Public: (01)10705036003359(17)290531(10)185D49
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2025

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: TX60G
• Device Lot Number: 185D49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 05/29/2025; 06/03/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/30/2025; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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