MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDO ILS 25MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number ECS25A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Month and day unknown.Only year (2019) is known.Batch #: t5ed1k.Device evaluation summary: the analysis results found that the ecs25a device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during a roux-en-y procedure, the surgeon felt the ecs25a washer did not ¿pop¿ as it normally should and could not hear it.After removing the device, the surgeon was able to see the staple lines anterior but not posterior.The donuts were checked, and they were complete, but the surgeon over sewed the staple line.An air leak test was performed, and it was successful.Concern was around the washer not cracking properly.There were no patient consequences reported.

• Brand Name: ENDO ILS 25MM, CURVED
• Type of Device: 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9473244
• MDR Text Key: 206948651
• Report Number: 3005075853-2019-24355
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003496
• UDI-Public: 10705036003496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940967
• 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: 11/20/2019

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: ECS25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1