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

Catalog Number	TLC75
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 5/4/2026.D4: batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi.Is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested and the following was obtained: at this stage no further information is available.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.Was the patient's hospital stay prolonged? if so, how long? what is the current status of the patient? please clarify what the patient consequences were? 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 after-hours acute case (urology re-look plus bowel resection), the colorectal component was performed by dr.During the bowel resection, a significant issue occurred involving the ethicon tlc75 device.The device was fired once without incident and the procedure continued.The device was then called upon for a second firing.The assisting nurse (orthopedic nurse, unfamiliar with the device) had not, or did not recall to, unload, clean, and reload the device.As a result, the device was fired a second time with the first spent reload still in place.Concerningly, the device did not lock out or otherwise prevent firing with a previously used reload.The knife transected the bowel, however no staples were deployed.Upon firing, the surgeon noted an absence of the normal resistance he would expect, being very familiar with the device.The standard pressure he applied resulted in the knife rapidly advancing to the end of the knife track.On reflection, the surgeon also noted that the closing handle prior to the second firing opened wider than would normally be expected, opening to approximately 90 degrees relative to the instrument body.Dr rectified the situation by repositioning the bowel and subsequently firing a tlc10 stapler over the defect.The patient is recovering well as of 1100h on (b)(6) 2026, but will continue to be monitored for a potential bowel leak.The procedure was delayed by un unk amount of time.

• Brand Name: PROXIMATE
• 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: 25073267
• Report Number: 3005075853-2026-03363
• Device Sequence Number: 18743794
• Product Code: GDW
• UDI-Device Identifier: 10705036013211
• UDI-Public: 10705036013211
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 05/04/2026

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: TLC75
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Sex: Unknown