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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-030115-UDH
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation / investigation: a visual inspection of the returned device was conducted. A review of complaint history, the device history record, quality control data, and specifications was also performed. One device was returned for investigation. A visual examination noted the support sheath and basket sheath are detached. There is 2. 5 cm of coil exposed from the distal end of the support sheath. The collet knob is tight and secure. The male lure lock adaptor (mlla) is tight. The polyethylene terephthalate tubing (pett) measures 3 cm in length. A kink is noted in the basket sheath 8. 2 cm from the distal tip of the basket sheath. Also returned with the stone extractor were a pin vise and a 10 cc syringe, neither of which is sold with the device. 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 and device integrity prior to shipping. 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. The device history record was reviewed and noted there were no non-conforming items identified during manufacturing. A review of complaint history revealed this is the only reported complaint associated with the complaint lot number ns7134996. Based on the provided information a definitive root cause could not be established. Per the quality engineering risk assessment, no further action is required. Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
 
Manufacturer Narrative
Unknown as information not provided by reporter. Blank fields on this form indicate the information is unknown or unavailable. (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 by the area representative that during preparation for an ureteroscopy procedure, after the package was opened containing the ncircle tipless stone extractor, it was found that the tip of the handle could not be moved. The device was not used. This device did not make patient contact. The patient did not require any additional procedures because of this device issue. The patient did not experience any adverse effects 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
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6857407
MDR Text Key196699457
Report Number1820334-2017-02868
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeTH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-030115-UDH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2016
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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