MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*55MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number	TLC55
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a general surgery, when they fired the stapler on the anastomosis, the stapler got stuck in the intestine and could not be opened.They cut out the stapler out of the intestine.No further information provided.
Additional Manufacturer Narrative
(b)(4).Date sent 11/10/2025.D4 batch #487d51.Investigation summary: the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the tlc55 device was received with no apparent damage, with no reload present.Upon visual inspection, the knife was found to have nicks.The damage on the knife is consistent when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Please reference the instruction for use for more information.The device was tested for functionality with a test reload and it fired, cut, and formed all the staples as intended.The staple line and cut line were complete, and the staples meet the staple form release criteria.The device opened as expected.The event described could not be confirmed as the device was returned without detectable damage, no reload was present and it opened and closed without difficulties.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.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 487d51, and no non-conformances were identified.The lot/batch 523d13 history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Additional information : the surgeon just emailed me and confirmed yes, there was patient harm.The stapler initially deployed halfway and then stopped.We couldn't move the staple forward or backwards and had to open the stapler; while stuck in mid-staple position.The bowel tore and what we were working on was destroyed.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: what were the indications for surgery? was there a complete stroke with the firing knob? what surgical procedure was performed? what anatomical structures was the device fired on? were other stapling or suturing devices used when creating the anastomosis? what device was used to create the common channel? what was used to close the common opening? were there any issues experienced with the device in the initial surgical procedure? was the device difficult to fire? how were the post-operative issues identified? did the device cut at all? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe.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.

• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23511212
• Report Number: 3005075853-2025-08673
• Device Sequence Number: 15879246
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: (01)10705036013204(17)300228(10)523D13(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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: TLC55
• Device Lot Number: 523D13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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