MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC KNOT PUSHER; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number KP1

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 08/11/2015

Event Type  malfunction  

Event Description

Three devices, same lot number, were opened onto sterile field and found to be defective.All devices of the same lot number were pulled from shelves.

• Brand Name: KNOT PUSHER
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 5110656
• MDR Text Key: 27020290
• Report Number: 5110656
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: KP1
• Device Lot Number: 60045801
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1