• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC NGAGE NITINOL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number G48294
Device Problems Loss of or Failure to Bond (1068); Break (1069); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) number = exempt.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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, 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
As reported, during an unspecified procedure, an ngage nitinol stone extractor basket could not be opened prior to use.Preliminary device evaluation found the basket had broken wires coming from the distal end of the sheath.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrections: d4: model # = gpn # h6: annex a and g investigation ¿ evaluation.As reported, during an unspecified procedure, an ngage nitinol stone extractor basket could not be opened prior to use.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Interview of personnel was also conducted.Functional tests and visual inspection of the returned complaint device was also conducted.One device was returned for investigation, in an open package with label.Handle was actuated, and the basket would not open/close.Basket had broken wires coming from distal end of sheath.Cook has concluded that the device was manufactured to specification.Additionally, 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 device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed one other related complaint associated with the failure mode for the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The ifu supplied with the device did not provide any information related to the reported issue.The returned device was found to have a basket that would not open due to separation of the basket from the basket sheath.The shrink tube and glue that secures the basket to the basket sheath had not held the two components together.The basket assembly is manufactured by a supplier.A project is in place to further investigate this failure mode.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
8123392235
MDR Report Key19058990
MDR Text Key339991530
Report Number1820334-2024-00482
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002482941
UDI-Public(01)10827002482941(17)260911(10)15649236
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 Other
Type of Report Initial,Followup
Report Date 09/06/2024
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 NumberG48294
Device Catalogue NumberNGE-017115
Device Lot Number15649236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received04/08/2024
Supplement Dates Manufacturer Received08/27/2024
Supplement Dates FDA Received09/06/2024
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
-
-