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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 UNKNOWN
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2020
Event Type  Injury  
Event Description
It was reported in a literature article from 2020, that the basket of a ncircle tipless stone extractor separated in the patient during a bilateral retrograde intrarenal surgery (rirs). A 62-year-old male underwent rirs for a 2cm right renal lower calyceal calculi. The patient¿s right renal stone was engaged by the device and an attempt was made to pull the stone out of the calyx but met resistance. The user then attempted to disengage the basket from the stone by opening and advancing the basket but the basket became entrapped around the stone. The user made a final attempt to forcefully remove the basket that was entrapped around the stone and the basket broke. The distal 4cm of the basket wire became entrapped around the stone and got disconnected from the proximal unit of the basket. The whole proximal unit of the basket was removed. The user then used a second tipless nitinol basket to attempt to remove the broken distal basket fragment but was unsuccessful. The user then proceeded with the rirs and laser lithotripsy to successfully fragment the lower calyx stone. After stone fragmentation, the user located the broken tip of the distal basket fragment in the renal pelvis. A third tipless nitinol basket was introduced through a flexible ureteroscope to grasp the fragment. The fragment was then retrieved through the ureteral access sheath without causing ureteral trauma. A double-j stent was placed and the procedure was completed. The rirs on the left calyx was successfully completed. A postoperative x-ray did not show any radiopaque shadow in the right renal area. The patient was discharged from the hospital one day postoperatively. The double-j stent was removed at 1 month. The patient had follow-up visits for two years following the procedure and did not report any complaints. A follow-up abdominal and pelvic ct did not show residual calculi or basket fragments.
 
Manufacturer Narrative
Article citation: sockkalingam, v. S. V. , palathullil, d. G. , radhakrishnan, v. Et al. Broken basket conundrum. Afr j urol 26, 31 (2020). Https://doi. Org/10. 1186/s12301-020-00041-w catalog # is unknown. Based on information provided the catalog # is either ntse-022115-udh or ntse-022115-udh-mb. Name and address: entity: vps lakeshore hospital nh-66 bypass, near police station, nettoor, maradu, kochi, kerala india postal code 682040. Correspondence: vigneswara srinivasan venkatachalapathy sockkalingam. Email: viwasri@gmail. Com pma/510(k) number: exempt. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key15065977
MDR Text Key296235084
Report Number1820334-2022-01240
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature
Reporter Occupation
Type of Report Initial
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/20/2022 Patient Sequence Number: 1
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