MAUDE Adverse Event Report: ETHICON ETHICON POWER STAPLER; ECHELON FLEX 45

Model Number PSE45A

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  Injury  

Event Description

Stapler misfired in pt.No injury related to pt.

• Brand Name: ETHICON POWER STAPLER
• Type of Device: ECHELON FLEX 45
• Manufacturer (Section D): ETHICON; cincinatti OH 45242
• MDR Report Key: 5675342
• MDR Text Key: 45859458
• Report Number: MW5062449
• Device Sequence Number: 1
• Product Code: GDW
• 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: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSE45A
• Device Lot Number: N90M7Y
• 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: 57 YR