MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 5MM ROUND TIP 45 CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSEAL545RH
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 1/27/2025 d4 batch #: k4ck5k.An analysis of the product could not be performed since a physical sample was not received for evaluation.Additional information was requested and the following was obtained: was the device used on a patient? if so, was there any patient consequence? no how was the product purchased? it was not delivered is there an indication of how the product was distributed? distributed by a natural person, no invoice is provided based on the packaging, is there any indication of which the original genuine product may have come from? no k4ck5k ¿ this batch was sold in ecuador between 2012 and 2013.This batch expired on march 31st, 2015.Expiry date informed in the product: 2027 ¿ 02.This is an analysis of an image submitted for evaluation.The images provided by the customer show a package label of product code nseal545rh, batch # k4ck5k, and expiration date: 2015-03.The lot number was reviewed, and it belongs to a nseal545rh device.Based on the lot trace performed, this product/lot was not approved to be sold in the region of this file complaint, therefore a confirmed tampering is confirmed.A manufacturing record evaluation was performed for the finished device batch number k4ck5k, and no non-conformances were identified.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 an indirect customer sent us photos of a product that was sold to him at a much lower price than the distributor quoted him.No patient involvement.

• Brand Name: ENSEAL 5MM ROUND TIP 45 CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21240941
• Report Number: 3005075853-2025-00645
• Device Sequence Number: 18268953
• Product Code: GEI
• UDI-Device Identifier: 10705036000051
• UDI-Public: (01)10705036000051(17)150331(10)K4CK5K
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K072493
• 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): 01/27/2025

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 Expiration Date: 03/31/2015
• Device Catalogue Number: NSEAL545RH
• Device Lot Number: K4CK5K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown