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

Model Number CDH25A

Device Problem Defective Component (2292)

Patient Problems Failure to Anastomose (1028); No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you please clarify when "there was a defect of stapling of a quarter of the circumference, " were there staples missing from the staple line (incomplete staple line)? or were unformed or malformed staples seen on the staple line? were there any patient consequences due to the event that occurred? was there any post-operative care change of the patient due to the event?.

Event Description

It was reported that during the intrathoracic peso-gastric anastomosis when a lewis santy esophagectomy was performed, no problem to snap the device to its anvil, or to tighten the 2 elements.But during stapling, there was a defect of stapling of a quarter of the circumference, forcing to cut a portion of the gastric plasty and remake a direct manual anastomosis.The operating time was extended by about 40 minutes, with increased tension on the anastomosis.Increased risk of anastomotic fistula.

Manufacturer Narrative

Product complaint # (b)(4).Batch # p58h7g.Device evaluation summary: the analysis results found that the cdh25a device arrived with the anvil missing.Only casing half washer was present and there were no staples present.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality with a test anvil.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.This report is not intended to deny that you experienced a problem with the device.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.

Manufacturer Narrative

(b)(4) date sent: (b)(6)2020.Additional information was requested, and the following was obtained: were there staples missing from the staple line (incomplete staple line)? no.Or were unformed or malformed staples seen on the staple line? no.Were there any patient consequences due to the event that occurred? yes, extended time of the procedure and more important resection with increased risk of fistula of the anastomosis.Was there any post-operative care change of the patient due to the event? increased surveillance and antibiotic therapy administered in post operative.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? were there difficulties with mobilization? what technique was used to secure the anvil (purse-string device, linear stapler, etc.)? what healthcare professional fired the device and what is his/her experience with the device? where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? was the device difficult to close? was the device difficult to fire? did the healthcare professional receive audible & tactile feedback when firing the device? were the donuts inspected? if so, please describe.Was a complete transection of the white breakaway washer visually confirmed? can more information be provided on what was meant by, ¿defect of stapling of a quarter of the circumference¿? please describe the shape of the staples.Did the increased tension noted contribute to the increased risk of anastomotic fistula? what is the current status of the patient?.

• Brand Name: ILS 25MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9371263
• MDR Text Key: 207043931
• Report Number: 3005075853-2019-23776
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: 10705036003458
• 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,Followup
• Report Date: 11/06/2019

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 Expiration Date: 10/01/2022
• Device Model Number: CDH25A
• Device Catalogue Number: CDH25A
• Device Lot Number: P4T71X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 01/17/2020
• Supplement Dates FDA Received: 12/20/2019; 02/10/2020
• Patient Sequence Number: 1