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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. RICHARD WOLF SEMI RIGID URETEROSCOPE URETEROSCOPE AND ACCESSORIES FLEX / RIGID

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RICHARD WOLF MEDICAL INSTRUMENTS CORP. RICHARD WOLF SEMI RIGID URETEROSCOPE URETEROSCOPE AND ACCESSORIES FLEX / RIGID Back to Search Results
Model Number 8708517
Device Problems Material Separation (1562); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/18/2019
Event Type  malfunction  
Event Description
The 4 french port on the wolf semi ridged scope was occluded by debris, causing the tip of the 0 top basket to shear off in the pt. Foreign body retrieval by dr (b)(6) was successful. Pt was not harmed. We feel device was not properly cleaned and handled down in prep and sterile. Fda safety report id# (b)(4).
 
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Brand NameRICHARD WOLF SEMI RIGID URETEROSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES FLEX / RIGID
Manufacturer (Section D)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
vernon hills IL 60061
MDR Report Key8735288
MDR Text Key149514637
Report NumberMW5087618
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8708517
Device Catalogue Number8708.517
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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