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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. URETERO-RENO-FIBERSCOPE FLEX-X² URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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KARL STORZ ENDOSCOPY-AMERICA, INC. URETERO-RENO-FIBERSCOPE FLEX-X² URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number FLEX-X2S
Device Problems Loose or Intermittent Connection (1371); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2020
Event Type  malfunction  
Event Description
The patient was undergoing bilateral ureteroscopies due to ureteral stones. Flexible ureteroscope placed into the left ureter. Laser was used to bust up the stones. As procedure continued, physician tried to pull the scope back. He met resistance and felt like the scope was stuck. Retraction techniques utilized/attempted. Rigid cystoscope utilized. Upon inspection, the outside lining of the flexible scope was very loose and was bunching.
 
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Brand NameURETERO-RENO-FIBERSCOPE FLEX-X²
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand avenue
el segundo CA 90245
MDR Report Key9852990
MDR Text Key184082452
Report Number9852990
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 Other Health Care Professional
Type of Report Initial
Report Date 03/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFLEX-X2S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/04/2020
Event Location Hospital
Date Report to Manufacturer03/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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