MAUDE Adverse Event Report: ETHICON ECHELON; LONG ENDOSCOPIC LINEAR CUTTER

Model Number EC45AL

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/26/2018

Event Type  Injury  

Event Description

After taking the renal artery with a single endo gia staple load, the renal vein was taken with endo gia staple load.This staple and fired and then cut, but the knife only retracted 3/4 of the way back and the stapler could not be removed.After finishing renal mobilization, the incisions had to be opened and the kidney removed openly, and the staple removed in similar fashion.This was a mechanical failure of the stapler itself.

• Brand Name: ECHELON
• Type of Device: LONG ENDOSCOPIC LINEAR CUTTER
• Manufacturer (Section D): ETHICON
• MDR Report Key: 7428527
• MDR Text Key: 105630818
• Report Number: MW5076473
• 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: 04/11/2018

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: 12/31/2019
• Device Model Number: EC45AL
• Device Lot Number: P9104X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2018
• 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): Hospitalization
• Patient Age: 40 YR