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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY

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COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Occupation: ir lead tech.Pma/510(k) #: preamendment.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 an ultrathane cope nephroureterectomy set was used for a nephroureteral catheter exchange.While trying to remove the flexible stiffener during the procedure, it became stuck in the catheter and caused the catheter to accordion.The catheter was removed with the stiffener and a new drain was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
 
Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and documentation were conducted during the investigation.The lot number of the device was no provided; accordingly, a review of the device history record could not be conducted.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided, no returned product and the results of the investigation, a definitive cause could (not) be established.The appropriate personnel have been notified per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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
ULTRATHANE COPE NEPHROURETEROSTOMY SET
Type of Device
LJE CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key8218793
MDR Text Key132222268
Report Number1820334-2019-00006
Device Sequence Number1
Product Code LJE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/04/2019
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 NumberULT10.2-10.2-26-NUCL-B-RH
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/14/2018
Initial Date FDA Received01/04/2019
Supplement Dates Manufacturer Received02/21/2019
Supplement Dates FDA Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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