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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°
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KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30° Back to Search Results
Model Number 24941BA
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/14/2025
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that "the telescope broke during the procedure" surgery was prolonged more than 60 min.No negative impact in state of health reported.Cross reference mdr: 9610617-2025-02218, 9610617-2025-02219, 9610617-2025-02221, 9610617-2025-02222.
 
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
HOPKINS TELESCOPE 30°
Common Device Name
HOPKINS TELESCOPE 30°
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key23700762
Report Number2020550-2025-02220
Device Sequence Number10670124
Product Code FAJ
UDI-Device Identifier04048551083789
UDI-Public04048551083789
Combination Product (Y/N)N
Initial Reporter CountryAR
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) 12/02/2025
Report Date (Section F) 12/02/2025
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 Number24941BA
Device Catalogue Number24941BA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/14/2025
Event Location Hospital
Date Report to Manufacturer12/02/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/02/2025
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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