MAUDE Adverse Event Report: ETHICON ENDO SURGERY INC. ETHICON ECHELON FLEX 60 POWERED PLUS STAPLER; ETHICON STAPLER

Model Number UNSURE

Device Problems Device Inoperable (1663); Unknown (for use when the device problem is not known) (2204)

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

Event Date 08/08/2016

Event Type  malfunction  

Event Description

Surgeon was performing a laparoscopic sleeve gastrectomy and hiatal hernia repair.Went to use the ethicon stapler and the device would not work.The device was replaced and the surgery completed without complications.The stapler and battery were removed and sequestered for risk management.Patient discharged home (b)(6) 2016.Risk does not have the package information so do not have the lot number, etc.

• Brand Name: ETHICON ECHELON FLEX 60 POWERED PLUS STAPLER
• Type of Device: ETHICON STAPLER
• Manufacturer (Section D): ETHICON ENDO SURGERY INC. ; 4545 creek rd.; cincinnati OH 15242
• MDR Report Key: 5939589
• MDR Text Key: 54439762
• Report Number: 5939589
• Device Sequence Number: 1
• Product Code: GDW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNSURE
• Device Lot Number: UNSURE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2016
• Distributor Facility Aware Date: 08/10/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2016
• 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: 43 YR