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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC FLEX-XC URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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KARL STORZ ENDOSCOPY-AMERICA, INC FLEX-XC URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 11278VU
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2016
Event Type  malfunction  
Event Description
While cleaning and testing the digital ureteroscope for the next surgical case, the spd technologist noted the ureteroscope developed a greater than 10mmhg leak during the leak test. The underwater test noted pin hole leak 40mm from distal end. Scope has not been in service especially long. Unit brought to biomedical for evaluation and reporting. Manufacturer response for digital video ureteroscope, (brand not provided) (per site reporter): manufacturer suggested that failure may have been contributed by laser firing while still inside the flexible scope lumen during the procedure. Biomedical requested additional testing and evaluation based on the size of the pinhole leak that occurred. Biomedical stating that size of pinhole leak not indicative of lasing action. This was the third occurrence of pinhole leaks developing on the bending rubber section of the scope.
 
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Brand NameFLEX-XC
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC
2151 e. grand ave
el segundo CA 90245
MDR Report Key5959491
MDR Text Key55022943
Report Number5959491
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 Biomedical Engineer
Type of Report Initial
Report Date 09/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11278VU
Device Catalogue NumberR11278VU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2016
Device Age18 DY
Event Location Hospital
Date Report to Manufacturer09/06/2016
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

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