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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG FLEX-X / IMAGE 1 S; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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KARL STORZ GMBH & CO. KG FLEX-X / IMAGE 1 S; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 11278VSUA
Device Problems Retraction Problem (1536); Structural Problem (2506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Event Description
The cladding part of the ureteroscope loosened and got displaced beyond the tip of the scope.It folded back on itself, thereby causing an inability to naturally be pulled out of the ureter.The surgeon resolved the issue by moving the ureteroscope further into the space to re-straighten the cladding.With this action, he was able to withdraw the scope without any harm to the patient.The event happened when the surgeon was ready to pull out the scope, after it was used.
 
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Brand Name
FLEX-X / IMAGE 1 S
Type of Device
URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG
2151 e. grand avenue
el segundo CA 90245
MDR Report Key11973996
MDR Text Key255361208
Report Number11973996
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 Risk Manager
Type of Report Initial
Report Date 06/02/2021
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
Device Operator Health Professional
Device Model Number11278VSUA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/02/2021
Event Location Hospital
Date Report to Manufacturer06/10/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24455 DA
Patient Weight117
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