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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Kinked (1339); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation. A review of complaint history, device history record, specification and quality control data was conducted during the investigation. The device was returned with the udh handle and the basket formation in the closed position. A visual examination noted the basket sheath has a severe kink at the base of the support sheath. A functional test was performed and the udh handle would not actuate the basket formation. There is no indication that a design or process related failure mode contributed to this event. Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. Based on the provided information, no conclusion can be drawn hence the root cause is unknown. We will notify the appropriate personnel and continue to monitor for similar complaints. Per the quality engineering risk assessment, we have notified the appropriate personnel of this event. No further action is required. Per the risk assessment no further action is required.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation.
 
Event Description
It was reported by the user facility that a patient underwent an ureteroscopy procedure. The attending physician attempted to extract a stone using the ncircle tipless stone extractor when the basket kinked in mid procedure and the wire partially detached from the basket. The physician replaced the basket and completed the procedure. No pieces from the detached basket were left in the patient nor did the patient experience any adverse effects or medical intervention due to this occurrence. No further information was provided.
 
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Brand NameNCIRCLE TIPLESS STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6331411
MDR Text Key196072996
Report Number1820334-2017-00185
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberNTSE-015115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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