MAUDE Adverse Event Report: COVIDIEN DST SERIES EEA 28MM SINGLE USE STAPLER; STAPLE, IMPLANTABLE, STAPLER

Catalog Number EEA28

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

Surgeon, who is experienced with the device, was using the stapling device to amputate a portion of the colon.When he squeezed the handle to release the device a portion of the stapling mechanism got stuck into the wall of the colon.He had difficulty removing it, but finally was able to get the remaining portion off the colon with no harm to the patient.Had he not been able to remove this portion of the device he would have had to open the patient to remove it surgically.

• Brand Name: DST SERIES EEA 28MM SINGLE USE STAPLER
• Type of Device: STAPLE, IMPLANTABLE, STAPLER
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 3899118
• MDR Text Key: 21805573
• Report Number: 3899118
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: EEA28
• Device Lot Number: P4B0593KX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2014
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 71