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

Model Number PSE45A

Device Problems Defective Component (2292); Component Missing (2306); Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 11/11/2014

Event Type  malfunction  

Event Description

During colorectal surgery, a powered endoscopic linear cutter was used 5 times to resect the sigmoid and rectum.On the 6th reload of the stapler, the device did not fire.The surgeon noted that cutter was defective and requested another device.The device was sent to biomedical engineering (bme) for analysis and return to the manufacturer.Bme noted the top plate of the cutter was missing.Photos were taken and the manufacturer was contacted for return and evaluation.

• Brand Name: ECHELON FLEX
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 4268326
• MDR Text Key: 16779535
• Report Number: 4268326
• 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
• Type of Report: Initial
• Report Date: 11/14/2014

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: Physician
• Device Model Number: PSE45A
• Device Catalogue Number: PSE45A
• Device Lot Number: L4F18H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2014
• Patient Sequence Number: 1
• Patient Age: 76 YR