MAUDE Adverse Event Report: COOK MEDICAL / COOK, INC. NCIRCLE; MITINOL TIPLESS STONE EXTRACTOR

Model Number NTSE-022115-UDH

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/21/2018

Event Type  malfunction  

Event Description

While operating the device, the basket being used broke.

• Brand Name: NCIRCLE
• Type of Device: MITINOL TIPLESS STONE EXTRACTOR
• Manufacturer (Section D): COOK MEDICAL / COOK, INC. ; bloomington IN 47404
• MDR Report Key: 7984289
• MDR Text Key: 124594317
• Report Number: MW5080689
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: 0100827002187788
• 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: 10/17/2018

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: 07/25/2018
• Device Model Number: NTSE-022115-UDH
• Device Catalogue Number: G18778
• Device Lot Number: 9045701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2018
• 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): Other
• Patient Age: 66 YR
• Patient Weight: 116