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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ FLEX -X2 URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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KARL STORZ SE & CO. KG KARL STORZ FLEX -X2 URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 11278AU1
Device Problem Component Missing (2306)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/24/2021
Event Type  malfunction  
Event Description
Rubber sheath over the distal end of the flexible ureteroscope was missing following a ureteroscopy for stent placement. Patient will be coming back in a couple of weeks for a second stone manipulation as the doctor did not get enough stone. Patient disclosed. Fda safety report id# (b)(4).
 
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Brand NameKARL STORZ FLEX -X2
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ SE & CO. KG
MDR Report Key11421761
MDR Text Key238403444
Report NumberMW5099801
Device Sequence Number1
Product Code FGB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11278AU1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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