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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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KARL STORZ ENDOVISION, INC. URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
Event Type  malfunction  
Event Description
Opened the flexible ureteroscope to be used during a case and could not attach stop cock to the valve of the scope. A piece of plastic from the tip of slip tip syringe was broken off and wedged in the valve.
 
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Brand NameURETEROSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ ENDOVISION, INC.
2151 e. grand avenue
el segundo CA 90245
MDR Report Key13108582
MDR Text Key282903082
Report Number13108582
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/20/2021
Event Location Hospital
Date Report to Manufacturer12/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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