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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
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2023
Event Type  malfunction  
Event Description
As reported, during the beginning of a flexible ureteroscopic lithotomy procedure, the basket of the circle tipless stone extractor would not open to gather a stone located in the kidney.The user retracted the basket from patient and found out the basket wire broken (the provided pictures and video shows the basket wire was detached from the cannula).The procedure was completed with another circle tipless stone extractor.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.E1- postal code= (b)(6).G4- pma/510(k) number: 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, 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.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: g2, h6 (annex a and annex g).Investigation ¿ evaluation: it was reported that the basket of a ncircle tipless stone extractor would not open to gather a stone located in the kidney during a flexible ureteroscopic lithotomy procedure.The user retracted the basket from the patient and discovered that a basket wire had "broken".The customer provided pictures and video show the basket wire was detached from the cannula.Another same device was used to complete the procedure.The patient experienced no harm as a result of the issue.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a functional test and visual inspection of the returned device and customer provided photographs and video, were conducted during the investigation.A device failure analysis was conducted on the returned device.Visual examination notes that the returned device was found to have had 1 of the 4 basket wires pulled free from the basket cannula that secures the proximal end of the basket wires in place.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr) which records no relevant non-conformances related to this incident.A database search for complaints on the reported lot found no additional complaints reported from the field.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; the ifu did not provide any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause for the wire separation could not be 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.
 
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Brand Name
NCIRCLE TIPLESS 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 Key17957534
MDR Text Key325945652
Report Number1820334-2023-01399
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002187785
UDI-Public(01)10827002187785(17)260531(10)15468167
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2024
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 NumberNTSE-022115-UDH
Device Lot Number15468167
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/11/2023
Initial Date FDA Received10/18/2023
Supplement Dates Manufacturer Received01/05/2024
Supplement Dates FDA Received01/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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