MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 3000 60MM LONG; STAPLE, IMPLANTABLE

Catalog Number ECH60L

Device Problems Component or Accessory Incompatibility (2897); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

It was reported that during the sleeve gastrectomy procedure after the first firing using green load, when they removed the reload, the second reload and when stapler was closed they could not insert jaws of stapler thorough the same 12 millimeter trocar.Due to a gap between anvil and cartridge stapler jaws which the reason it was not able to fit through.Another like device was used to complete the procedure.There were no patient consequences.Buttress was used.

Manufacturer Narrative

(b)(4).Date sent: 12/4/2023.D4: batch # 176c81.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one ech60l device was returned with the anvil bent upwards and without reload present.As additional testing, the device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.It is possible that the device was clamped over an excess of tissue causing the anvil to bend.Please reference the instruction for use for more information.  as part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 176c81, and no non-conformances were identified.

• Brand Name: ECHELON 3000 60MM LONG
• Type of Device: 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: 18259953
• MDR Text Key: 329683391
• Report Number: 3005075853-2023-09036
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036034988
• UDI-Public: 10705036034988
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: ECH60L
• Device Lot Number: X96G47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1