MAUDE Adverse Event Report: COOK MEDICAL N-COMPASS NITINOL EXTRACTOR

Model Number G32701

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2014

Event Type  malfunction  

Event Description

During ureteroscopy with stone manipulation the n-compass nitinol stone extractor failed with the basket failing to close on multiple attempts.No harm to pt.

• Brand Name: N-COMPASS NITINOL EXTRACTOR
• Type of Device: N-COMPASS NITINOL EXTRACTOR
• Manufacturer (Section D): COOK MEDICAL; bloomington
• MDR Report Key: 5401798
• MDR Text Key: 37336173
• Report Number: MW5059800
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/27/2016

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 Model Number: G32701
• Device Lot Number: 5171438
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR