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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ KARL STORZ, 7.5 FR FLEXIBLE URETEROSCOPE

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KARL STORZ KARL STORZ, 7.5 FR FLEXIBLE URETEROSCOPE Back to Search Results
Model Number 11278AU1
Device Problem Microbial Contamination of Device (2303)
Patient Problems Fever (1858); Septic Shock (2068)
Event Date 11/01/2016
Event Type  Injury  
Event Description
Pt underwent urological procedure with 7. 5 fr flex x2 ureteroscope on (b)(6) and was discharged home in stable condition. Returns to ed on (b)(6) 2016 with fever, and is transferred to icu in septic shock. Pt grows e. Faecalis from urine culture. Second pt undergoes similar urological procedure on (b)(6) 2016 with the same scope and becomes ill shortly after requiring transferred icu. Blood cultures grow e. Faecalis. Scope is pulled from service and sampled, culture results are negative with no growth. No known colonization of e. Faecalis in either pt.
 
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Brand NameKARL STORZ, 7.5 FR FLEXIBLE URETEROSCOPE
Type of Device7.5 FR FLEXIBLE URETEROSCOPE
Manufacturer (Section D)
KARL STORZ
el segundo CA
MDR Report Key6099529
MDR Text Key59789115
Report NumberMW5066011
Device Sequence Number1
Product Code FGB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number11278AU1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 11/10/2016 Patient Sequence Number: 1
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