MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ECHELON FLEX 35MM STAPLER; STAPLE, IMPLANTABLE

Lot Number T93684

Device Problems Failure to Advance (2524); Misfire (2532)

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

Event Date 06/11/2019

Event Type  malfunction  

Event Description

Physician was performing a resection of the pancreas when the echelon 35 stapler misfired.It was stated the stapler did not deploy any staples, but the knife still cut.There is no documentation of pt injury in the op notes by the physician.Fda safety report id# (b)(4).

• Brand Name: ECHELON FLEX 35MM STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 8726959
• MDR Text Key: 149079149
• Report Number: MW5087543
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014584
• UDI-Public: (01)10705036014584
• 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: 06/19/2019

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 Expiration Date: 04/30/2022
• Device Lot Number: T93684
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2019
• 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: 72 YR