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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

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COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL Back to Search Results
Model Number G49898
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2023
Event Type  malfunction  
Event Description
As reported, when the package of a universa firm ureteral stent set was opened.The stent was discovered bent.A new same device was used to complete the procedure.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
 
Manufacturer Narrative
E1: name and address: (b)(6).H3: device has been returned, and preliminary evaluation has been performed.However, our investigation is ongoing.And device evaluation summary will be included in our follow up report once our investigation has been completed.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.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.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a representative of (b)(4), informed cook on 12apr2023 of an incident involving an universa firm ureteral stent set (ufh-526-r) from lot 15084445.Reportedly, on 06apr2023, the user opened the package and found the stent to be bent.They changed to another of the same device to complete the procedure.This incident did not result any adverse effects.Reviews of the complaint history, device history record, and quality control procedures, as well as a visual inspection of the device, were conducted during the investigation.One device was returned to cook for evaluation.It was noted that the proximal stent coil was bent and misshapen.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 lot 15084445 revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in 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 was unable to review the product labeling as the lot was ifu exempt.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause of the bend was not able to be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.¿ per a review of risk documentation, 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.
 
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Brand Name
UNIVERSA FIRM URETERAL STENT SET
Type of Device
FAD STENT, URETERAL
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 Key16877137
MDR Text Key314719571
Report Number1820334-2023-00558
Device Sequence Number1
Product Code FAD
UDI-Device Identifier10827002498980
UDI-Public(01)10827002498980(17)251122(10)15084445
Combination Product (y/n)N
PMA/PMN Number
K161236
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 08/09/2023
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 NumberG49898
Device Catalogue NumberUFH-526-R
Device Lot Number15084445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received05/05/2023
Supplement Dates Manufacturer Received07/17/2023
Supplement Dates FDA Received08/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2022
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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