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

Catalog Number	TX30B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the device did not staple before cutting.Risk of bleeding.Risk of infection by contamination by intestinal matter.
Additional Manufacturer Narrative
(b)(4).Date sent 12/5/2023.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.Additional information was requested, and the following was obtained: 1.Since tx30b is just a stapler device and doesn't cut, could you please provide more details of the device malfunction? 2.Please confirm the device product code.3.Could you please clarify if there were any patient consequences? 4.Could you please clarify if there were any changes in the post-operative care of the patient as a result of the event? answer: no further relevant information.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.
Additional Manufacturer Narrative
(b)(4), date sent: 12/12/2023.Additional information was requested, and the following was obtained: 1.Since tx30b is just a stapler device and doesn't cut, could you please provide more details of the device malfunction? no further information available.2.Please confirm the device product code.Tx30b according to the file but the device has been shipped to analysis so the customer can not check.3.Could you please clarify if there were any patient consequences? 4.Could you please clarify if there were any changes in the post-operative care of the patient as a result of the event? nothing special is mentioned in his medical records.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/2/2024.D4: batch #316a57.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 revealed that the tx30b device arrived with no apparent damaged and with a reload loaded on the device.The reload was received fully fired.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 as part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: make sure tissue to be stapled is properly positioned in the jaws before stapling.Bunching, stretching, or uneven loading of tissue could result in leakage, lack of hemostasis, or disruption of staple line.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.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number 316a57, 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 ; PR ; 3035526892
• MDR Report Key: 18268335
• Report Number: 3005075853-2023-09061
• Device Sequence Number: 4006498
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: 10705036003311
• 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
• Report Date (Section B): 02/02/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: TX30B
• Device Lot Number: 324A20
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 01/08/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/12/2023; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2021
• 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