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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTRSE-100038
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/17/2021
Event Type  Injury  
Event Description
As reported, approximately one year after a lithotripsy with stone removal in which a perc ncircle nitinol tipless stone extractor and another manufacturer's nitinol stone retrieval basket were used, a nitinol basket was discovered in the patient's renal pelvis with a large stone detached. This was identified during a foreign body retrieval procedure. It is unknown which of the two devices separated and remained in the patient. Additional event information has been requested.
 
Manufacturer Narrative
Boston scientific zero tip nitinol stone retrieval basket (m0063901050). Pma/510(k) #- 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 NamePERC NCIRCLE NITINOL 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
8128294891
MDR Report Key13533778
MDR Text Key285612386
Report Number1820334-2022-00225
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 Other,Health Professional,User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTRSE-100038
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/19/2022
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: 02/15/2022 Patient Sequence Number: 1
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