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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ KARL STORZ CYSTOSCOPE SHEATH 20 FRENCH

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KARL STORZ KARL STORZ CYSTOSCOPE SHEATH 20 FRENCH Back to Search Results
Model Number 27028-CA
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/09/2017
Event Type  Injury  
Event Description
Beak end of the 20 french cystoscope fractured off in the patient's bladder.
 
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Brand NameKARL STORZ CYSTOSCOPE SHEATH 20 FRENCH
Type of DeviceCYSTOSCOPE SHEATH
Manufacturer (Section D)
KARL STORZ
GM
MDR Report Key6416750
MDR Text Key70433674
Report NumberMW5068534
Device Sequence Number1
Product Code FAJ
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 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27028-CA
Device Lot NumberUW03
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?
Type of Device Usage

Patient Treatment Data
Date Received: 03/15/2017 Patient Sequence Number: 1
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