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

Model Number 020250

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while on colon during a laparoscopic low anterior resection, the size may have been too large and tore the tissue.When it was extracted from the patient, the staple line seemed intact.They tried to oversew but the tissue was bad.Eventually, they removed the anastomosis and redid with the same device which was smaller in diameter to complete the case.The surgical time was extended by more than 30 minutes due to the product problem.

• 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: 8019546
• MDR Text Key: 125487065
• Report Number: 1219930-2018-05746
• 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: 10/30/2018

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: 10/03/2018
• Initial Date FDA Received: 10/30/2018
• 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