MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ECHELON FLEX; STAPLER, SURGICAL

Catalog Number PLEE60A

Device Problems Defective Component (2292); Mechanics Altered (2984)

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

Event Date 08/23/2016

Event Type  malfunction  

Event Description

Dr was using an ethicon articulating linear stapler and went to fire it, with the articulating end at an angle, and the device would not stay at the angle he had it set at.The device would involuntarily return to a straightened position.The room staff scrapped the defective stapler and opened a new one.Manufacturer response for plee60a, (brand not provided) (per site reporter): ethicon will investigate this problem and determine whether or not it was an isolated incident.

• Brand Name: ECHELON FLEX
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 3801 university blvd se; albuquerque NM 87106
• MDR Report Key: 6046720
• MDR Text Key: 58066337
• Report Number: 6046720
• Device Sequence Number: 0
• Product Code: GDW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/24/2016,09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PLEE60A
• Device Lot Number: N92C67
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2016
• Event Location: Other
• Date Report to Manufacturer: 08/24/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1