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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 20 FR.
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KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 20 FR. Back to Search Results
Model Number 27026C
Medical Device Problem Codes Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/21/2025
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
 
Event or Problem Description
It was reported that the tip of the instrument 27026c broken during surgery and was subsequently removed from the patient's bladder.The duration of the surgical prolongation was between 15 and 60 minutes.No negative impact in state of health reported.
 
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Brand Name
CYSTOSCOPE SHEATH, 20 FR.
Common Device Name
CYSTOSCOPE SHEATH, 20 FR.
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen,
GM 
MDR Report Key23511990
Report Number2020550-2025-02035
Device Sequence Number9732760
Product Code OBD
UDI-Device Identifier04048551074176
UDI-Public04048551074176
Combination Product (Y/N)N
Initial Reporter CountryTW
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/10/2025
Report Date (Section F) 11/10/2025
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? Yes
Operator of Device Health Professional
Device Model Number27026C
Device Catalogue Number27026C
Device Lot NumberED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/22/2025
Event Location Hospital
Date Report to Manufacturer11/10/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/10/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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