MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 28MM SINGLE-USE STAPLER; STAPLER, SURGICAL

Model Number EEA28

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).User facility listed in initial reporter.(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.

Event Description

According to the reporter, during a sigmoid resection, the device closed and fired but when the surgeon went to open, the anvil would not flip.Ultimately became disconnected from the stapler and the anvil was stuck in the anastomosis.Had to redo the anastomosis.Surgeon did hear the click on the turn and the green line was visualized.Only the anvil is available for return.The packaging was thrown away so the lot number is not available.There was no reinforcement material used.

Event Description

Additional information provided by the account: the patient was not injured.No complications were reported.

• Brand Name: EEA 28MM SINGLE-USE STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6258026
• MDR Text Key: 64993171
• Report Number: 2647580-2017-00057
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention