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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INCORPORATED NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number G48296
Device Problems Failure to Unfold or Unwrap (1669); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2017
Event Type  malfunction  
Event Description
Product would not uncoil and engage. Product did not have patient contact and there was no patient harm.
 
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Brand NameNGAGE
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key7373148
MDR Text Key103551031
Report Number7373148
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG48296
Device Catalogue NumberNGE-022115-MB
Device Lot Number7737558
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/08/2018
Event Location Hospital
Date Report to Manufacturer03/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/27/2018 Patient Sequence Number: 1
Treatment
UNKNOWN.
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