• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION CMOS VIDEO URETEROSCOPE, 8.5 FR. X 675MM FLEXIBLE URETEROSCOPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KARL STORZ ENDOVISION CMOS VIDEO URETEROSCOPE, 8.5 FR. X 675MM FLEXIBLE URETEROSCOPE Back to Search Results
Model Number 11278VAK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
We were informed a lawsuit was filed and no additional information is available at this time.
 
Event Description
Customer described to us the patient lost a kidney during a procedure. Multiple scopes from different companies were used and the facility is not sure which one contributed to this event. Per customer, during a cystoscopy, ureteroscopy, laser lithotripsy, retrograde, right ureter procedure, right urs with laser lithotripsy with avulsion of the right ureter. Physician stated equipment worked as it is intended to work. Hospitalization was necessary and the patient was then discharged and transferred to another facility, (b)(6), on (b)(6) 2019.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCMOS VIDEO URETEROSCOPE, 8.5 FR. X 675MM
Type of DeviceFLEXIBLE URETEROSCOPE
Manufacturer (Section D)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton MA 01507
Manufacturer (Section G)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton MA 01507
Manufacturer Contact
susie chen
2151 east grand avenue
el segundo, CA 90245-5017
MDR Report Key8916130
MDR Text Key155067966
Report Number1221826-2019-00070
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number11278VAK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-