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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STORZ ENDOSKOP PRODUKTIONS GMBH STORZ 11278AU1 (FLEX-X) SCOPE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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STORZ ENDOSKOP PRODUKTIONS GMBH STORZ 11278AU1 (FLEX-X) SCOPE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 11278AU1
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2022
Event Type  malfunction  
Event Description
During ureteroscopy doctor visualized foreign material/object in pt's right ureter. Object appears blue in color, was retrieved via basket and observed by staff. It was determined to be a small portion of the flexible ureteroscope that was in use, scope was passed off the field and incident reported to product rep. Damaged scope reported to spd, passed off the field and new flexible ureteroscope was used for duration of the case. No detectable harm to the pt. Fda safety report id # (b)(4).
 
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Brand NameSTORZ 11278AU1 (FLEX-X) SCOPE URETEROSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
STORZ ENDOSKOP PRODUKTIONS GMBH
MDR Report Key13251919
MDR Text Key283947025
Report NumberMW5106633
Device Sequence Number1
Product Code FGB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11278AU1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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