MAUDE Adverse Event Report: ETHICON ECHELON FLEX 45 ENDOSCOPIC STAPLER

Model Number SC45A

Device Problem Difficult to Open or Close (2921)

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

Event Date 06/26/2017

Event Type  malfunction  

Event Description

Two echelon flex 45 would not open while the appendix or launch the staplers; was able to get the stapler open to get off the pt's appendix.This pt was pregnant which made it a higher risk case.

• Brand Name: ECHELON FLEX 45 ENDOSCOPIC STAPLER
• Type of Device: ENDOSCOPIC STAPLER
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6680420
• MDR Text Key: 79027243
• Report Number: MW5070729
• 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
• 2 Devices were Involved in the Event: 1 2

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 Model Number: SC45A
• Device Lot Number: P91R5G
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2017
• 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 Outcome(s): Other
• Patient Age: 41 YR