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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 Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2017
Event Type  malfunction  
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
The customer reported that the ngage nitinol stone extractor basket malfunctioned towards the end of an intended right ureteroscopy with laser lithotripsy and stone extraction procedure, when the physician was attempting to remove another stone from the patient's body.The malfunction was described as the basket would not deploy out of the sheath.The customer used another ngage nitinol stone extractor basket to retrieve the remaining stones and successfully completed the procedure.No unintended section of the device remained inside the patient¿s body.The patient did not require an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
The following methods were performed during the investigation: dimensional verification, functional test, review of complaint history, review of device history record, review of quality control, and visual inspection of the device.The document based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of device history record and quality documentation shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.A visual examination of the returned device noted a kink in the basket sheath 83 cm from the distal tip and the support sheath is partially severed 1 mm from the mlla tubing.The back of the support sheath shows stress marks but it did not severe.A functional test was performed and the unidex handle (udh) would not actuate the basket formation.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.Per the quality engineering risk assessment no further action is required.
 
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Brand Name
NCIRCLE TIPLESS STONE EXTRACTOR
Type of Device
FFL 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 Key6553455
MDR Text Key74706954
Report Number1820334-2017-00837
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002187788
UDI-Public(01)00827002187788(17)190913(10)7268573
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 Other
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberNTSE-022115-UDH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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