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

Catalog Number	TX60B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unk procedure, the clamp was placed and the stapler was fired.The operator then performed a transection using the cold blade at the high rectal level.When the clamp was opened, it was found that there were no staples in the cartridge.The rectum then ended up open into the abdominal cavity.The surgeon had to perform a lower transection at the mid-rectal level.As a consequence, the patient required the creation of a protective ileostomy, which had not been planned in the initial operative strategy.A different tx60g clamp was then used to transect the mid-rectum.
Additional Manufacturer Narrative
(b)(4) date sent: 2/20/2026 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was obtained: as a consequence, the patient required the creation of a protective ileostomy, which had not been planned in the initial operative strategy.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 any staples observed in the surgical field from this firing? if so, what was their shape? what was the thickness of the tissue being fired upon? was there any difficulty in closing the device? was this the first firing of the device? or had it been reloaded? 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: 3/23/2026.D4: batch # 307d73.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the tx60b device arrived with no apparent damage and with a reload no loaded on the device.The reload was received fully fired.Upon visual inspection of the cartridge, the vision system witness mark was present on the reload indicating that the reload was inspected for staple presence by an automated vision system.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.The event described could not be confirmed as the device performed without any difficulties noted.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Device history review: a manufacturing record evaluation was performed for the finished device batch number 307d73, and no non-conformances were identified.Additional information was requested and the following was obtained: were any staples observed in the surgical field from this firing? no staples because zero staples in feeder.If so, what was their shape? no staples.What was the thickness of the tissue being fired upon? rectum about 6 cm.Was there any difficulty in closing the device? no difficulty.Was this the first firing of the device? or had it been reloaded? the first firing.

• Brand Name: PROXIMATE
• 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: 24401741
• Report Number: 3005075853-2026-01495
• Device Sequence Number: 8168275
• Product Code: GDW
• UDI-Device Identifier: 10705036003342
• UDI-Public: (01)10705036003342(17)300331(10)533D35
• 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
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TX60B
• Device Lot Number: 533D35
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown