MAUDE Adverse Event Report: COVIDIEN STAPLER; CIRCULAR STAPLER

Model Number EEA 33 MM

Device Problem Misfire (2532)

Patient Problem Injury (2348)

Event Date 04/15/2019

Event Type  Injury  

Event Description

Pt came to operating room for resection of portion of colon due to perforation.During the procedure dr (b)(6) and dr (b)(6) were reconnecting remaining sigmoid bowel to rectum via covidien stapler (eea 33 m - 4.8 mm circular stapler).Upon removal of the stapler after firing (was within green and turned 2 full turns prior to removing) it was noted that the stapler miss fired and did not fully penetrate to tissue causing a clonic injury to the rectum portion.Due to this the pt required a colostomy placement when she otherwise would not have needed one and will now need to come back to surgery for colostomy reversal in the future.

• Brand Name: STAPLER
• Type of Device: CIRCULAR STAPLER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8578157
• MDR Text Key: 144018481
• Report Number: 8578157
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEA 33 MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2019
• Event Location: Hospital
• 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): Required Intervention
• Patient Age: 78 YR