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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO KG FLEX-X2S; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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KARL STORZ SE & CO KG FLEX-X2S; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number FLEX X 2S
Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Perforation (2001)
Event Date 11/07/2019
Event Type  Injury  
Event Description
Patient was undergoing a cystoscopy, right retrograde pyelogram, and ureteroscopy with laser lithotripsy.Per the operative report, a complication was encountered when the ureteroscope became stuck in the mid ureter upon withdrawal.The provider had difficulty withdrawing or advancing.The scope was successfully withdrawn after very gentle rotation of scope and sheath.The ureter suffered a perforation.Md noted "it appeared that the sheathing came off the ureteroscope causing the perforation." a stent was placed to treat the perforation.The patient was admitted for observation.
 
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Brand Name
FLEX-X2S
Type of Device
URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ SE & CO KG
2151 e grand avenue
el segundo CA 90245
MDR Report Key9340491
MDR Text Key166953125
Report Number9340491
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberFLEX X 2S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2019
Event Location Hospital
Date Report to Manufacturer11/19/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age20805 DA
Patient Weight98
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