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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ 22 FR CYSTOSCOPE SHEATH

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KARL STORZ 22 FR CYSTOSCOPE SHEATH Back to Search Results
Model Number 27086BA
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 03/17/2016
Event Type  Injury  
Event Description

Pt was undergoing cystoscopy and end of cystoscope sheath fractured off. Defect noted to be at weld site.

 
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Brand Name22 FR CYSTOSCOPE SHEATH
Type of Device22 FR CYSTOSCOPE SHEATH
Manufacturer (Section D)
KARL STORZ
charleton MA 01507
MDR Report Key5517449
MDR Text Key40937038
Report NumberMW5061095
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation NURSE
Type of Report Initial
Report Date 03/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number27086BA
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/18/2016 Patient Sequence Number: 1
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