MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. INTRALUMINAL STAPLER; STAPLER, SURGICAL

Catalog Number CDH29A

Device Problems Failure to Form Staple (2579); Firing Problem (4011)

Patient Problem Failure to Anastomose (1028)

Event Date 09/18/2019

Event Type  malfunction  

Event Description

During sigmoidectomy, two (2) separate ethicon staplers did not fire correctly, there was a malfunction.See the following info from op report - pt w/diagnosis of sigmoid obstruction undergoing a sigmoidectomy - we placed a 29eea sizer through the rectum and we were able to get to our staple line.We cleaned out the rectum as well as we could.There was a significant amount of barium within the rectum.We placed the anvil into the distal colon and tied our purse [invalid].There was a small gap that was closed off with a 3-0 silk suture.The stapler was then deployed into the rectum and the spike deployed just anterior to the staple line.The spike was connected to the anvil and retracted in the mid portion of the green marker.The stapler was then fired and did not fire normally.It was removed and on leak test was noted the anterior 270 degrees of the staple line, there appeared to be no staples involved.Did not feel like we could salvage the anterior portion of the staple line.We excised the old staple line off the proximal colon, which was very dilated at this point.We once again placed a stapler through the rectum and deployed anterior to the staple line and brought the anvil down and fired the stapler in similar fashion as before.Again there was a large leak on the proximal portion and our staple line was not intact.Did not feel we could salvage the anastomosis so it was taken down and contour stapler was fired across the rectum.We irrigated out the abdomen and felt like we were relegated to a colostomy which was performed.Fda safety report id# (b)(4).

• Brand Name: INTRALUMINAL STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 9145742
• MDR Text Key: 161257191
• Report Number: MW5090150
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2019

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: 05/31/2024
• Device Catalogue Number: CDH29A
• Device Lot Number: T40L59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 110