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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2023
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1- customer (person): postal code: (b)(6) // phone:(b)(6).E3- occupation: theatre support officer.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.
 
Event Description
It was reported that the basket wires of an ngage nitinol stone extractor detached from the basket sheath prior to a planned procedure.Device was not used in the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
 
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 unknown, unavailable, or unchanged.Correction: d10, h6 annex g summary of event: it was reported that the basket wires of an ngage nitinol stone extractor detached from the basket sheath prior to a planned procedure.Device was not used in the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control (qc) procedures were conducted during the investigation.A visual inspection was conducted as well.The complaint device was returned to cook for investigation.The basket formation had separated from the distal end of the basket sheath.A document-based investigation evaluation was performed.Three related non-conformances were noted.However, all affected product was scrapped and there are 100% inspections in place to capture the non-conformance.One other complaint had been reported for this lot.The two complaints are related.The product ifu [t_shef_rev1] did not provide any information related to the reported issue.Adequate inspection activities had been established, and there was objective evidence that the dhr was fully executed there was not sufficient evidence to conclude that nonconforming product exists in house or in field.The information provided upon review of the dmr, dhr, ifu, returned device, and complaint file suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a cause could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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
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 Key17721149
MDR Text Key323095054
Report Number1820334-2023-01217
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002482941
UDI-Public(01)10827002482941(17)260530(10)15465462
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/28/2024
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-017115
Device Lot Number15465462
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/01/2023
Initial Date FDA Received09/11/2023
Supplement Dates Manufacturer Received03/27/2024
Supplement Dates FDA Received03/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2023
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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