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

Catalog Number	TLC55
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/9/2026.D4: batch # unk.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: 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? no patient involved pre-opertive, thus n/a.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 during an unk procedure, upon opening the secondary packaging, they discovered that the primary packaging had already been opened.As the product is therefore no longer sterile and consequently unusable.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/2/2026.D4: batch # 696d28.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that one tlc55 device was returned inside its opened package; upon visual inspection, the package was undamaged, but the tyvek was noted to have the seal misaligned and spottiness on the blister seal area were noted.However, the package meets the minimum seal width requirement, and the sterile barrier is not compromised.Based on the information currently available, a product issue was identified during the investigation of the sample received.The issue with the tyvek is potentially related to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.The event could not be confirmed as the sterility was not compromised and there is not an open channel.Device history review: a manufacturing record evaluation was performed for the finished device batch number of 696d28 / 43tlc55, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2026.Correction: h6.

• 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: 24296242
• Report Number: 3005075853-2026-01166
• Device Sequence Number: 10213209
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: (01)10705036013204(17)300731(10)696D28
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 04/22/2026

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: TLC55
• Device Lot Number: 696D28
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 04/10/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/02/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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
• Patient Sex: Unknown