MAUDE Adverse Event Report: COOK MEDICAL NGAGE NITINOL STONE EXTRACTOR 1.7 FR + 1/5CM

Catalog Number NOE-017115, GPN-G48294

Device Problem Mechanics Altered (2984)

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

Event Date 06/13/2014

Event Type  malfunction  

Event Description

Upon inspection before use, it was discovered the tip (working end) of the basket was malfunctioning (not closing all the way).It was removed from the field and replaced with a new one.

• Brand Name: NGAGE NITINOL STONE EXTRACTOR 1.7 FR + 1/5CM
• Type of Device: NGAGE NITINOL STONE EXTRACTOR 1.7 FR + 1/5CM
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 3893820
• MDR Text Key: 4423615
• Report Number: MW5036788
• Device Sequence Number: 1
• Product Code: FFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/01/2014
• Device Catalogue Number: NOE-017115, GPN-G48294
• Device Lot Number: U2480458
• Patient Sequence Number: 1