MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Model Number 020250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Tissue Damage (2104); No Code Available (3191)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: occurred during an open sigmoid resection procedure.This was an emergency procedure being performed to repair a tear in the sigmoid colon that occurred while the patient was undergoing a colonoscopy.It was reported that the stapler sizer also tore the tissue and had to be repaired using suture.Then the stapler was inserted trans-anally into the distal bowel and fired to anastomose the proximal and distal bowel.Upon inspection, the anastomosis was reported to have not been fully developed.The surgeon then used a smaller stapler to successfully perform the anastomosis.Finally, a diverting ileostomy was performed.Unknown at this time if the ileostomy was temporary or permanent.The surgical time was extended by more than thirty minutes due to the product problem.The was patient injury.

• Brand Name: EEA
• Type of Device: SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8747959
• MDR Text Key: 149629155
• Report Number: 1219930-2019-03853
• Device Sequence Number: 1
• Product Code: KOA
• UDI-Device Identifier: 10884521047471
• UDI-Public: 10884521047471
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2019

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: 020250
• Device Catalogue Number: 020250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 07/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention