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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-015115
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/26/2017
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable. A review of documentation, drawing, manufacturing instructions, quality control, specifications, functional test and visual inspection was completed during this investigation. One device was returned for investigation. The device was returned with the handle in the open position and the basket formation in the open position. There were no kinks or damage noted in the basket sheath. A functional test determined the handle actuated the basket formation without issue. A visual examination noted that one of the basket wires has the appearance of being caught on or pulled by something. There are no other complaints associated with this lot number. Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event. Based on the provided information a definitive cause cannot be established at this time. Appropriate personnel have been notified 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 during a transurethral lithotripsy procedure, the ncircle tipless stone extractor was advanced to the target site transurethrally through a flexible ureteroscope. After the device reached the target area, the physician attempted to open the basket, but it did not expand properly. Therefore, he retrieved the extractor out of the body and confirmed a bend in one of the four basket wires used. Another device was used and the procedure was completed successfully. No adverse effects or consequences were reported to the patient due to this occurrence.
 
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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
MDR Report Key7178311
MDR Text Key286444575
Report Number1820334-2018-00027
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002462069
UDI-Public(01)00827002462069(17)200822(10)8163085
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-015115
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

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