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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM
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KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM Back to Search Results
Model Number 28300BA
Medical Device Problem Code Optical Problem (3001)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 08/07/2025
Type of Reportable Event Serious Injury
Event or Problem Description
The following was reported: optical breakage during the itv.The surgery had to be postponed and a prolonged hospitalization was required.Therefore, the case is deemed reportable.
 
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).
 
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Brand Name
HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM
Common Device Name
HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key23064704
Report Number2020550-2025-01506
Device Sequence Number9849814
Product Code HRX
UDI-Device Identifier04048551111628
UDI-Public04048551111628
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) 09/16/2025
Report Date (Section F) 09/16/2025
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 Number28300BA
Device Catalogue Number28300BA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/07/2025
Event Location Hospital
Date Report to Manufacturer09/16/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/16/2025
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 Required Intervention; Other; Hospitalization;
Patient SexUnknown
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