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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG FLEX-X URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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KARL STORZ GMBH & CO. KG FLEX-X URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 11278VUA
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2016
Event Type  malfunction  
Event Description
During cleaning and processing of digital ureteroscope, technician noted excessive leakage greater than 10mmhg/second from scope. Scope isolated and sent to biomedical engineering for inspection and communication with manufacturer. Biomed confirmed greater than 10mmhg/sec pressure drop on test gauge indicating major leak in endoscope. This is a reoccurring report on this particular failure with these digital scopes. Reference previous medwatch report. Manufacturer response for ureteroscope, digital, flex (per site reporter): this is an on-going issue with these failures. Manufacturer requesting device sent in for evaluation of failure. Biomedical requesting formal report of failure to be returned for risk management evaluation and to be placed into record.
 
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Brand NameFLEX-X
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG
600 corporate pointe
culver city CA 90230
MDR Report Key6212805
MDR Text Key63533819
Report Number6212805
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 12/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11278VUA
Device Catalogue Number11278VUA
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2016
Device Age10 DY
Event Location Hospital
Date Report to Manufacturer12/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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