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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number N/A
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Patient Involvement (2645)
Event Date 05/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).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.
 
Event Description
It was reported that the user checked the integrity of the ncircle delta wire tipless stone extractor before use and found out the basket cannot be retracted.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
 
Event Description
It was reported that the user checked the integrity of the ncircle delta wire tipless stone extractor before use and found out the basket cannot be retracted.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
 
Manufacturer Narrative
Conclusion code: 4315, cause not established.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and trends.One device was returned for investigation.The device was returned with the handle and the basket formation in the open position.The collet knob is tight and secure.The male luer lock adapter (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 3 cm in length.There were no kinks noted in the basket sheath.A functional test determined the handle actuates the basket formation; but when the handle is in the closed position, 5 mm of the basket formation protrudes from the basket sheath.The handle was disassembled.The basket formation does manually actuate.The support sheath and the basket sheath are still adhered.The handle was reassembled and the distal tip of the basket formation still protrudes 5 mm.The device history lot record was reviewed and noted there were no non-conformances associated with the complaint device lot number.A search of complaint records found this is the only complaint associated with lot number 8178915.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The instructions for use (ifu) contains the following information in the precautions section: enclose the device in the sheath before removing from the tray/holder.Do not use excessive force to manipulate this device.Damage to the device may occur.The complaint device was found to have a basket that would not fully close, with 5mm of the basket extending out of the sheath when the handle was in the fully closed position.No damage was noted to the device.The device was disassembled and the components were found to freely move.The device was reassembled and the basket was still found to extend 5mm when fully closed.The cause for the failure of the basket to fully close could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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.
 
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Brand Name
NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Type of Device
FFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7582122
MDR Text Key110484488
Report Number1820334-2018-01683
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002191105
UDI-Public(01)00827002191105(17)200829(10)8178915
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/29/2020
Device Model NumberN/A
Device Catalogue NumberNTSED-024115-UDH
Device Lot Number8178915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Date Manufacturer Received07/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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