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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY FLEXIBLE URETEROSCOPE
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KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY FLEXIBLE URETEROSCOPE Back to Search Results
Model Number R11278AUK1
Medical Device Problem Code Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code Perforation (2001)
Date of Event 03/03/2017
Type of Reportable Event Malfunction
Event or Problem Description
Allegedly, the hospital stated that during a ureteroscopy procedure the doctor could not remove scope from patient.They cut the shaft from the handle to remove scope.The patient sustained a small perforation to the ureter and a stent was used for an extended period of time.The doctor used another ureteroscope to complete procedure.The doctor states patient condition is good.
 
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Brand Name
FLEXIBLE URETEROSCOPE
Common Device Name
FLEXIBLE URETEROSCOPE
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
mittlestrasse 8,
78503
tuttlingen, germany,
GM 
MDR Report Key6474278
Report Number1221826-2017-00024
Device Sequence Number582141
Product Code FGB
UDI-Device Identifier04048551226438
UDI-Public4048551226438
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K982905
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Model NumberR11278AUK1
Device Catalogue NumberR11278AUK1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/07/2017
Initial Report FDA Received Date04/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age55 YR
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