MAUDE Adverse Event Report: COVIDIEN COVIDIEN; STAPLER

Lot Number PP6JOO66X

Device Problems Failure to Form Staple (2579); Difficult to Open or Close (2921)

Patient Problem Blood Loss (2597)

Event Date 01/11/2017

Event Type  Injury  

Event Description

The covidien stapler used to staple and cut tissue locked in the closed position for a period of time, when the jaws of the stapler were opened the stapler had cut but not stapled, resulting in blood loss.Diagnosis or reason for use: was being used in vascular surgery.

• Brand Name: COVIDIEN
• Type of Device: STAPLER
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 6266983
• MDR Text Key: 65501279
• Report Number: MW5067360
• Device Sequence Number: 1
• Product Code: GAG
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PP6JOO66X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 87