MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. COH29A CIRCULAR POWERED STAPLER, ECHELON; STAPLER, SURGICAL

Model Number CDH29A

Device Problem Misfire (2532)

Patient Problem Tissue Damage (2104)

Event Date 03/23/2018

Event Type  Injury  

Event Description

Went into (b)(6) hospital - (b)(6) for a sigmoid colectomy procedure.During the reconnect process, the ¿echelon (cdh29a) circular powered stapler¿, ¿misfired¿, according to the doctor's report from the hospital.As a result of the misfire, my rectal stump/colon was damaged, and i now have a colostomy and must wear a bag.My ostomy has become extremely herniated.It has dramatically changed my lifestyle.It is expensive ¿(thousands of $$$)¿, time and resource consuming.It is embarrassing to venture out in public.Please help me.

• Brand Name: COH29A CIRCULAR POWERED STAPLER, ECHELON
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 8416833
• MDR Text Key: 138763811
• Report Number: MW5084881
• 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: Patient
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDH29A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 88