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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 Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation - a review of the quality control system was conducted during the investigation. The device was not returned to assist with the investigation. 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. This device will not be returned and no photos have been provided. A review of non-conformance data could not be performed as no lot number was provided. A search for additional complaints could not be performed as no lot number was provided. If this information becomes available, this record will be updated accordingly. Based on the provided information a definitive root cause cannot be established or reported at this time. We will continue to monitor for similar complaints.
 
Manufacturer Narrative
This event is currently under investigation. A follow-up report will be generated upon the completion of the investigation.
 
Event Description
The customer reported that when trying to introduce the device into the scope, the flexible shaft that surrounds the basket buckled trying to get through the nipple of the scope. The physician continued to try to introduce the basket into the scope but the buckling persisted. The patient did not experience any adverse effects as a result of this event.
 
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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 Key6365356
MDR Text Key196205403
Report Number1820334-2017-00419
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberNTSE-022115-UDH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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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