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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NFORCE NITINOL HELICAL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NFORCE NITINOL HELICAL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NFHSES-032115-3W-UDH
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation
=
unknown. 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, after opening the package of an nforce nitinol helical stone extractor, it was discovered that the metal wire at the front end of the sheath at the handle was broken. The issue with this device was discovered prior to making contact with the patient and it was not used. Another same type device was used to completed the procedure. There was no impact to the patient.
 
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Brand NameNFORCE NITINOL HELICAL 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 Key14775203
MDR Text Key303236340
Report Number1820334-2022-01101
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002179407
UDI-Public(01)10827002179407(17)241221(10)14433394
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNFHSES-032115-3W-UDH
Device Lot Number14433394
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2021
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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