MAUDE Adverse Event Report: COVIDIEN, LLC COVIDIEN CIRCULAR STAPLER; STAPELER, SURGICAL

Lot Number P8L1586Y

Device Problem Failure to Form Staple (2579)

Patient Problem Failure to Anastomose (1028)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

Surgeon used the 28 mm covidien eea circular stapler and when fired, it did not produce an adequate staple line, and the anastomosis did not work.It did create perfect "donuts", and the person operating the equipment said it did fire, but the staple line was not adequate.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN CIRCULAR STAPLER
• Type of Device: STAPELER, SURGICAL
• Manufacturer (Section D): COVIDIEN, LLC; mansfield MA
• MDR Report Key: 8757442
• MDR Text Key: 150122617
• Report Number: MW5087779
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Lot Number: P8L1586Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 69 YR