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

Catalog Number	TX60B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/24/2025.D4: batch # unk.The manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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 part resection for the small intestine, they used the tx60b, but the staple line was not complete.They took another xr60b reload with the same result.They open another tx60b and they finished the operation without any problems.The patient suffered no harm!.
Additional Manufacturer Narrative
(b)(4).Date sent 10/28/2024.D4 batch #827c24.Investigation summary : the analysis results showed that the tx60b device was received a reload loaded and with the retaining pin arm broken and the broken piece was not returned.In addition, a second reload (b) was received.Both reloads were received fully fired with no apparent damage.The device was tried to test with a test reload and it closed normally, however, the firing trigger was stuck and it could not be fired due to the condition of the pin arm.No functional test could be performed due to the condition of the device.Due to the reloads received were fully fired, we are unable to investigate further the event description as the device could not be fired.The damage to the pin arm is possible that the device encounter higher firing forces than normal resulting in a damaged component.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: the firing stroke must be completed.Do not partially fire the instrument.Incomplete firing can result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.Squeeze the closing trigger and the handle fully together until a second click is heard.The closing trigger is now latched to the handle and the jaws are clamped onto the tissue, which is ready to be stapled.The firing trigger will simultaneously move down to the ready-to-fire position.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 827c24, and no non-conformances were identified.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20291150
• Report Number: 3005075853-2024-07173
• Device Sequence Number: 7996449
• Product Code: GDW
• UDI-Device Identifier: 10705036003342
• UDI-Public: (01)10705036003342(17)290131(10)890C35
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/28/2024

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: TX60B
• Device Lot Number: 890C35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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