MAUDE Adverse Event Report: COVIDIEN; EEA STAPLER

Lot Number P6E0056KX

Device Problems Defective Device (2588); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  malfunction  

Event Description

Surgeon asked that an eea 28/4.8 stapler be opened.The stapler was opened by the circulator and passed to the surgical tech.Later, it was brought to the attention of the circulator, by surgical tech and first assist, that the stapler appeared to be defective; it was noted that staples were protruding from the stapler opening, even though the device had not been activated.

• Type of Device: EEA STAPLER
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 6680419
• MDR Text Key: 79026661
• Report Number: MW5070728
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Lot Number: P6E0056KX
• 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: 73 YR
• Patient Weight: 92