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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL
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KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL Back to Search Results
Model Number 27040XA
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/03/2026
Type of Reportable Event Malfunction
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Brand Name
INNER SHEATH, FOR 27040 SD/SL
Common Device Name
INNER SHEATH, FOR 27040 SD/SL
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, deu 78532 ,
GM  78532,
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, deu 78532 ,
GM   78532,
Manufacturer Contact
anja fair
2151 e. grand avenue
el segundo, CA 90245
4242188247
MDR Report Key25894937
Report Number9610617-2026-01681
Device Sequence Number18589329
Product Code HIH
UDI-Device Identifier04048551076521
UDI-Public04048551076521
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K221893
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Foreign,Health Professional,User Facility,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/21/2026
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
Operator of Device Health Professional
Device Model Number27040XA
Device Catalogue Number27040XA
Device Lot NumberRO12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2026
Initial Report FDA Received Date07/21/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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