MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 29MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH29A

Device Problems Component Missing (2306); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Event Description

It was reported that during an anterior resection procedure, they did everything as per instructions for use and when they tried to fire the device, there was no crunch sound of the washer.After inspection, realized that there was no knife and only staples were deployed.Had to transect the stapled portion to prepare for re-anastomoses with another device.Surgery was successfully completed and there was no patient consequence reported.

Manufacturer Narrative

(b)(4).Batch p58e1p.Investigation summary: the analysis results found that the cdh29a device arrived with no apparent damage.The breakaway washer uncut and there were no staples present.The device was reloaded with staples and tested for functionality with a test washer; the device 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 condition of the washer indicates that the device had not been fired through a full firing stroke or possibly that the orange indicator was not fully into the safe green firing range.It should be noted that before firing the device the orange indicator should be fully within the green range of the gap setting scale.In addition, it should be noted that if the firing sequence is not complete (the firing handle reaches its stopping point, and the firing trigger is parallel to the instrument handle) staples could be partially deployed without cutting the washer.Please reference the instructions for use for additional information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ILS 29MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8625839
• MDR Text Key: 145628715
• Report Number: 3005075853-2019-19247
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003465
• UDI-Public: 10705036003465
• Combination Product (y/n): N
• PMA/PMN Number: K983536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Catalogue Number: CDH29A
• Device Lot Number: P4T620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Date Manufacturer Received: 05/27/2019
• Patient Sequence Number: 1