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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH RICHARD WOLF SHEATH CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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RICHARD WOLF GMBH RICHARD WOLF SHEATH CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 8654.3742
Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261)
Patient Problem No Information (3190)
Event Date 09/28/2017
Event Type  Injury  
Event Description
Tip of sheath 8654. 3742 fragmented and fell off during cystoscopy laser procedure.
 
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Brand NameRICHARD WOLF SHEATH
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
RICHARD WOLF GMBH
MDR Report Key6940222
MDR Text Key89232719
Report NumberMW5072677
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8654.3742
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 10/11/2017 Patient Sequence Number: 1
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