MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 3000 45MM LONG; STAPLE, IMPLANTABLE

Catalog Number	ECH45L
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the lap appendectomy procedure that upon opening the device a "moisture" like film was inside the clear plastic sleeve that covers most of the jaw.Two devices were opened in the procedure with this "moisture" like film.A third like device was used to continue with the procedure.There were no adverse consequences reported.After the procedure their inventory was checked and another three were found to have this substance on them as well.
Additional Manufacturer Narrative
(b)(4).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/24/2024 d4: batch # c9d99x investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection were conducted on the returned device.Visual analysis of the returned sample revealed that one ech45l device was returned inside its package unopened; upon visual inspection, excess of lubricant was noted in the jaws and the joint cover area.In addition, no issues were observed related to integrity and the seal area was noted completed.During the manufacturing process, a clear lubricant is applied to the articulation joint cover to make the insertion and extraction of the device into the trocar easier.The lubricant is sodium stearate; this is known to be matter non-toxic and biologically non-hazardous that is attributable to the assembly process.This lubricant is safe for patient use.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.Device history review a manufacturing record evaluation was performed for the finished device lot number c9d99x, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/14/2024.Corrected data: h6 medical device problem code.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a malfunction, and has been revised to a not reportable event.

• Brand Name: ECHELON 3000 45MM LONG
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20152774
• Report Number: 3005075853-2024-06599
• Device Sequence Number: 15518641
• Product Code: GDW
• UDI-Device Identifier: 10705036034964
• UDI-Public: (01)10705036034964(17)261231(10)C9D99X
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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: ECH45L
• Device Lot Number: C9D99X
• 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: 08/10/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/30/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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