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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
Catalog Number NTSE-022115-UDH
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation: a review of functional testing, documentation, drawing, manufacturing instructions, visual inspection, specifications, and quality control data was conducted during the investigation. Visual inspection and functional testing of the returned device were performed. One device was returned for investigation. The device was returned with the handle partially open. The collet knob is tight and secure. The mlla (male luer lock adaptor) is loose. The pett measures 3 cm in length. The support sheath and basket sheath are still adhered. A functional test determined the handle does not actuate the basket formation. A visual examination noted the tip of the basket sheath is smashed approximately 1 mm from the distal tip. There is a small kink 47. 2 cm from the distal tip. No patient harm was reported. 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 investigation evaluation, there is no indication that a design or process related failure mode contributed to this event. Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping. Based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time. We will notify the appropriate personnel and continue to monitor for similar complaints.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
It was reported that the basket broke on a ncircle tipless stone extractor while in use. No adverse events have been reported as a result of the alleged malfunction. Request for additional information regarding lot number, patient information, date of event, and procedure being performed have been made, however, the customer has not provided any further information.
 
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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 Key7151792
MDR Text Key269396157
Report Number1820334-2017-04587
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 03/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
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 Received02/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
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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