MAUDE Adverse Event Report: COOK INCORPORATED NCIRCLE NITINOL TIPLESS STONE EXTRACTOR; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number G18778

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/16/2020

Event Type  malfunction  

Event Description

During cystoscopy with ureteroscopy with removal/manipulation of stones, a small piece of the distal portion of the ncircle nitinol tipless stone extractor from cook medical broke off.Piece was unable to be retrieved and was retained in patient's ureter.Fda safety report id# (b)(4).

• Brand Name: NCIRCLE NITINOL TIPLESS STONE EXTRACTOR
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 10319990
• MDR Text Key: 200600280
• Report Number: MW5095702
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G18778
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 10242147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 67 YR
• Patient Weight: 100