MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number	LT300
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/15/2025.D4 batch #n4lf32.Photo analysis: this is an analysis of a sample submitted for evaluation.During the visual analysis, the following was observed: a sterile reload package with product code lt300, lot # n4lf32, exp.Date: 2028-11-01.The n4lf32 lot number was finding in our quality tracking system with product code lt300, date of mfg 2016-04-25 and expiration date 2021-03-31.The expiration date on the suspect package does not match any information in our johnson & johnson/ethicon endo-surgery systems.Additionally, the part number (a95141p00) was examined on our quality tracking system and there is a significant difference observed between the suspect packages and the authentic packages/artwork.Typos were observed, such as "ll.C", which are not present in genuine packaging.The analysis performed determines that the suspect package is not authentic johnson & johnson product.Based on the discrepancies in expiration date, artwork, and system records, the counterfeit product is confirmed.A manufacturing record evaluation was performed for the finished device batch number n4lf32, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.How was the product purchased? product was bought by the investigator conducting a test purchase.2.Could you please confirm if the vendor is authorized by (b)(4) ¿ vendor is not authorized.3.Is there an indication of how the product was distributed? no.4.Is there any indication of the source? no.5.Based on the packaging, is there any indication of which market the original genuine product may have come from? no.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 global brand protection latam team has conducted a test purchase in peru from two unauthorized and suspicious sellers.The details of all purchased products are listed below.Please initiate a product complaint to document the test purchase, and thoroughly check the products, batches, and expiry dates to verify potential counterfeit or diversion.The batch was not found in the j&j system, as shown in the attached file.Confirmation of this information is required to qa team.There are signs of potential counterfeiting, including typos, which raise suspicion of counterfeit elements.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/24/2025.D4: batch #n4lf32.Investigation summary: the product and packaging pictures were received at ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned sample and pictures of the packaging.Visual analysis of the returned sample revealed that one lt300 sterile cartridge with lot # n4lf32, exp.Date: 2028-11-01 was returned with no apparent damage.The returned sample was visually compared against an original lt300 test cartridge.The following observations were noted during the visual inspection.The received sample present a clearer shade of green than test reload.The received sample does not show cavity number, test reload shows different cavity number in number and letter.The pattern of clip body and leg of received sample shows nonconformities according the compared test clip.Returned clip was thinner than the compared test clip.The n4lf32 lot number was found in our quality tracking system with product code lt300, date of mfg 2016-04-25 and expiration date 2021-03-31.The expiration date on the suspect package does not match any information in our johnson & johnson/ethicon endo-surgery systems.Additionally, the part number (a95141p00) was examined on our quality tracking system and there is a significant difference observed between the suspect packages and the authentic packages/artwork.Typos were observed, such as "ll.C", which are not present in genuine packaging.The analysis performed determines that the suspect package is not authentic johnson & johnson product.The received complaint sample is confirmed as counterfeit product.A manufacturing record evaluation was performed for the finished device batch number n4lf32, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2025.D4: batch # n4lf32.Investigation summary: this is an analysis of a sample submitted to ethicon endo surgery for evaluation.During the visual analysis, the following was observed: a sterile reload package with product code lt300, lot # n4lf32, exp.Date: 2028-11-01.The n4lf32 lot number was finding in our quality tracking system with product code lt300, date of mfg 2016-04-25 and expiration date 2021-03-31.The expiration date on the suspect package does not match any information in our johnson & johnson/ethicon endo-surgery systems.Additionally, the part number (a95141p00) was examined on our quality tracking system and there is a significant difference observed between the suspect packages and the authentic packages/artwork.Typos were observed, such as "ll.C", which are not present in genuine packaging.The analysis performed determines that the suspect package is not authentic johnson & johnson product.Based on the discrepancies in expiration date, artwork, and system records, the counterfeit product is confirmed.According to the information received, the lt300 cartridge reported suspect counterfeit product.The product and packaging pictures were received at ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned sample and pictures of the packaging.Visual analysis of the returned sample revealed that two lt300 two sterile cartridges with lot # n4lf32, exp.Date: 2028-11-01 were returned with no apparent damage.The returned sample was visually compared against an original lt300 test cartridge.The following observations were noted during the visual inspection.The received sample present a clearer shade of green than test reload.The received sample does not show cavity number, test reload shows different cavity number in number and letter.The pattern of clip body and leg of received sample shows nonconformities according the compared test clip.Returned clip was thinner than the compared test clip.The n4lf32 lot number was found in our quality tracking system with product code lt300, date of mfg 2016-04-25 and expiration date 2021-03-31.The expiration date on the suspect package does not match any information in our johnson & johnson/ethicon endo-surgery systems.Additionally, the label of the part number ((b)(6) was examined on our quality tracking system and there is a significant difference observed between the suspect packages and the authentic packages/artwork.Typos were observed, such as "ll.C", which are not present in genuine packaging.The analysis performed determined that the suspect package is not authentic johnson & johnson product.The received complaint sample is confirmed as counterfeit product.Device history review a manufacturing record evaluation was performed for the finished device batch number n4lf32, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number n4lf32, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/5/2026.Investigation summary: the product and packaging pictures were received at ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned sample and pictures of the packaging.Visual analysis of the returned sample revealed that three lt300 sterile cartridges with lot # n4lf32, exp.Date: 2028-11-01 were returned with no apparent damage.The returned samples were visually compared against an original lt300 test cartridge.The following observations were noted during the visual inspection.The received samples present a clearer shade of green than test reload.The received samples do not show cavity number, test reload shows different cavity number in number and letter.The pattern of clip body and leg of received samples shows nonconformities according the compared test clip.Returned clip was thinner than the compared test clip.The n4lf32 lot number was found in our quality tracking system with product code lt300, date of mfg 2016-04-25 and expiration date 2021-03-31.The expiration date on the suspect package does not match any information in our johnson & johnson/ethicon endo-surgery systems.Additionally, the label of the part number (a95141p00) was examined on our quality tracking system and there is a significant difference observed between the suspect packages and the authentic packages/artwork.Typos were observed, such as "ll.C", which are not present in genuine packaging.The analysis performed determined that the suspect package is not authentic johnson & johnson product.The received complaint sample is confirmed as counterfeit product.Device history review a manufacturing record evaluation was performed for the finished device batch number n4lf32, and no non-conformances were identified.

• Common Device Name: CLIP, 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; 3035526892
• MDR Report Key: 23299683
• Report Number: 3005075853-2025-08034
• Device Sequence Number: 4798118
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: (01)10705036012825(17)210331(10)N4LF32
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830503
• 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,Followup
• Report Date (Section B): 03/05/2026

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 Expiration Date: 03/31/2021
• Device Catalogue Number: LT300
• Device Lot Number: N4LF32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 10/31/2025; 11/25/2025; 02/16/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/24/2025; 12/12/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2016
• 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