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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 Problems Break (1069); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
Pma/510k # ¿ exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
As reported, during an unspecified procedure, an ncircle tipless stone extractor broke at the "attachment" to the handle. The basket was unable to be redeployed. No adverse events have been reported as a result of the alleged malfunction. Additional information has been requested. At the time of this report, no further information has been provided.
 
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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 Key13580909
MDR Text Key296076458
Report Number1820334-2022-00286
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002187785
UDI-Public(01)10827002187785(17)240812(10)14150085
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 04/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number14150085
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2021
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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