MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST WHITE RELOAD, 45MM, 6 ROW; STAPLE, IMPLANTABLE

Catalog Number	GST45W
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 11/11/2025 d4: batch #unk d4: udi: as the lot number for the device involved in the event was not recognized, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.Additional information was requested, and the following was obtained: could you please provide the device lot#/batch#? added as serial number how was the product purchased? ip litvinenko.Based on the packaging, is there any indication of which market the original genuine product may have come from? no was the device used on a patient? if so, was there any patient consequence? no 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.Investigation summary: this is an analysis for the photos submitted for evaluation.During the visual analysis, the following was observed: the photos show a box with product code gst45w, lot # 258c54, exp.Date: 2028-03-15.A dhr review was performed on the lot provided, and lot number 258c54 associated with the product code gst45w was not found in the quality tracking system.The analysis performed determines that the suspect package is not authentic johnson & johnson product.Based on the photos reviewed, it was confirmed that the product is counterfeit.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 the customer received allegedly defective products.There was no patient consequence reported.No additional information provided.

• Brand Name: GST WHITE RELOAD, 45MM, 6 ROW
• 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 00969 ; * 00969 ; 3035526892
• MDR Report Key: 23524445
• Report Number: 3005075853-2025-08730
• Device Sequence Number: 10202784
• Product Code: GDW
• UDI-Device Identifier: 10705036014928
• UDI-Public: 10705036014928
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K163454
• 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): 11/11/2025

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: GST45W
• Device Lot Number: 258C54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/11/2025
• 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
• Patient Sex: Unknown