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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ FLEX-X FLEXIBLE URETOSCOPE URETEROSCOPE

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KARL STORZ FLEX-X FLEXIBLE URETOSCOPE URETEROSCOPE Back to Search Results
Model Number 11278AU1
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2015
Event Type  malfunction  
Event Description
Physician reported that the scope was "bunched up. " uncertain as to how damage occurred. There was no visible scope damage prior to use. Manufacturer response for flexible ureteroscope, flex-x flexible ureteroscope (per site reporter): major damage to angle cover (torn apart) caused by cleaning/disinfection.
 
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Brand NameFLEX-X FLEXIBLE URETOSCOPE
Type of DeviceURETEROSCOPE
Manufacturer (Section D)
KARL STORZ
2151 e. grand avenue
el segundo CA 90245
MDR Report Key5781713
MDR Text Key49157317
Report Number5781713
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11278AU1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2016
Event Location Hospital
Date Report to Manufacturer07/07/2016
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

Patient Treatment Data
Date Received: 07/11/2016 Patient Sequence Number: 1
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