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

Catalog Number	TLC75
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/9/2026.B3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch#: 723d21.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 tlc75 device was received with the anvil shroud broken and with a reload loaded.The reload was received unfired and the swing tab in unlocked position.Upon visual inspection of reload, some protruding staples were observed on the middle part of the reload and slightly marks of body fluids were noted on the reload deck.Also, no package was received for analysis.No functional test was performed due to the condition of the device.No conclusion could be reached as to how the damage to the device occurred, it is possible that the damage was due to improper handling of the device.Please reference the instruction for use for more information.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 of 723d21 / 43tlc75, and no non-conformance's were identified.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.Did the damage occur right out of the packaging or in the operative field? was part of the packaging found to be damaged (tyvek, plastic/blister, packaging seal, etc.)? or, was there difficulty opening the packaging material (difficulty removing/peeling back the tyvek)? could you please identify the packaging (shipping box, primary packaging, box, pouch seal, or the plastic bag)? could you please clarify the type of damage found (broken, packaging was worn, bent, ragged, containing cut or slit, or appear ripped)? was sterility compromised as a result of the packaging damage? please provide a picture (if available) is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? 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 before an unk procedure, the outer plastic box is defective.The handle on the upper part is removed.No patient involvement.

• 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: 24831206
• Report Number: 3005075853-2026-02680
• Device Sequence Number: 10430406
• Product Code: GDW
• UDI-Device Identifier: 10705036013211
• UDI-Public: (01)10705036013211(17)300731(10)723D21
• 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
• Report Date (Section B): 04/09/2026

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: TLC75
• Device Lot Number: 723D21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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