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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 Material Separation (1562)
Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)
Event Date 07/24/2018
Event Type  Injury  
Manufacturer Narrative
Medical devices: 6mm ureteral balloon dilator used prior to stone extraction and rigid cystoscope 6fr. Occupation: non-healthcare professional. Pma/510(k) #: exempt (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was initially reported, during a cystoscopy with retrograde pyelogram (rpg) and stone manipulation procedure, the basket of a ncircle tipless stone extractor broke off in the ureter as extraction was taking place. As reported, a ureteral stent was placed and the patient was sent home, the basket remained in the patient. A second procedure will be required to remove the stone and basket from the ureter. Additional information was received (b)(6) 2018, the patient had a follow-up procedure on (b)(6) 2018 and the broken portion of the basket and stone were successfully removed. As reported, the patient returned to the emergency room (er) at a later time and was admitted to the hospital with likely diagnosis of post-operative infection. Per the facility risk manager, the patient was admitted to the hospital with an infection, but she had no additional details. Per the facility risk manager the patient has been released from the hospital. Requests were made for additional information regarding; further details of the event, however, the customer has not provided any further information. No additional patient consequences were reported.
 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7789913
MDR Text Key117325611
Report Number1820334-2018-02349
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,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number8850446
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/16/2018 Patient Sequence Number: 1
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