MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	SC45A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gbp latam team performed a test purchase in colombia due to a suspicious seller.Product sc45a ¿ batch k4ck6z - suspicious of tampering ¿ this batch invalid ¿ there is inscription ¿muestra sin valor commercial¿.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/18/2024 d4: batch # unk investigation summary the reported event for the sc45a device was suspect tampering.This is an analysis of the photos submitted to ethicon endo surgery for evaluation.During the visual analysis, the following was observed: the photo shows a packaging, code sc45a.In addition, the tyvek has a label attached to it in the lot area and expiration date with lot # k4ck6z, exp.Date: 2026-08.Lot number was reviewed, and it belongs to a sc45a device.The expiration date printed on the label does not match with the expiration date recorded on the quality tracking system 2016-03-30.Additionally, the labels on the packaging are not from j&j.Based on the photos reviewed, the tampered product is confirmed.Additional information was requested and the following was obtained: ¿ how was the product purchased? test purchase performed by a gbp supplier.¿ is there an indication of how the product was distributed? no, it is part of the investigation.¿ is there any indication of the source? no ¿ 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 ¿ is a photo available of the product? yes.

• Brand Name: ECHELON FLEX 45 COMPACT
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20250783
• Report Number: 3005075853-2024-07016
• Device Sequence Number: 20992136
• Product Code: GDW
• UDI-Device Identifier: 10705036002697
• UDI-Public: 10705036002697
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K051002
• 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): 09/18/2024

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: SC45A
• Device Lot Number: K4CK6Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/18/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown