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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL
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KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL Back to Search Results
Model Number 27050XA
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Serious Injury
Event or Problem Description
According to the information received, a part of the sheath detached and migrated into the patient's bladder during the procedure.
 
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
INNER SHEATH FOR 27050 SL
Common Device Name
INNER SHEATH FOR 27050 SL
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key21748822
Report Number2020550-2025-00539
Device Sequence Number15811857
Product Code HIH
UDI-Device Identifier04048551078136
UDI-Public04048551078136
Combination Product (Y/N)N
Initial Reporter CountryFR
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) 04/01/2025
Report Date (Section F) 04/02/2025
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 Number27050XA
Device Catalogue Number27050XA
Device Lot NumberSR04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer04/02/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/01/2025
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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