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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 11278 VU
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2016
Event Type  malfunction  
Event Description
The cysto scope failed the leak test after the surgery and before it was processed by sterile processing. We have had 12 broken scopes including most with failed leak tests in the past 7 months. We only own 2 scopes so several have been replaced several times. We have had the vendor watch 2 days of cases and nothing failed during those 2 days. Manufacturer response for cysto fiber scope, (brand not provided) (per site reporter): they are evaluating the device for defects and operator abuse. They stated that the scopes have an average of 10 uses before some form of repair is needed.
 
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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 avenue
el segundo CA 90245
MDR Report Key5916999
MDR Text Key53658151
Report Number5916999
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
Type of Report Initial
Report Date 07/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11278 VU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2016
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer07/26/2016
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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