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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 HEALTH PROFESSIONAL
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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