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U.S. Department of Health and Human Services

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

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COOK INC NGAGE NITINOL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number N/A
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Event Description
It was reported that an ngage nitinol stone extractor's basket did not open when tested prior to patient contact, during an unknown procedure.The device was tested in an uncoiled position.No visible damage noticed on the device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: (b)(6).G4 - 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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Manufacturer Narrative
Investigation ¿ evaluation: it was reported that an ngage nitinol stone extractor's basket did not open when tested prior to patient contact, during an unknown procedure.The device was tested in an uncoiled position.No visible damage noticed on the device.The procedure was completed with another same-like device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One ngage nitinol stone extractor was returned in an open package with label.The returned device was found to have a basket that was closed and could not be opened.The basket sheath and yellow support sheath were found to be bent at the handle.No damage was found by the user, and the device was returned loose in original pouch without the shipping tray; making it likely the bent sheaths occurred during return shipping and was not the cause of the issue.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other complaints associated with the reported device lot.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product ifu, t _ ntse_ rev1, provides the following information to the user: precaution: do not use excessive force to manipulate this device.Damage to the device may occur.Based on the information provided, inspection of the returned device, and the results of the investigation, no cause for the failure of the basket to open was established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
Additional information received 31may2024: the procedure was complete with another same-like device.
 
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Brand Name
NGAGE NITINOL STONE EXTRACTOR
Type of Device
FFL 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 Key18839742
MDR Text Key336976137
Report Number1820334-2024-00293
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002482972
UDI-Public(01)10827002482972(17)260911(10)15650768
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberNGE-022115
Device Lot Number15650768
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/22/2024
Initial Date FDA Received03/05/2024
Supplement Dates Manufacturer Received05/31/2024
Supplement Dates FDA Received06/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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