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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.
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KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR. Back to Search Results
Model Number 27294AA
Medical Device Problem Code Poor Quality Image (1408)
Health Effect - Clinical Code Insufficient Information (4580)
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
According to the information received, the image was blurry.In consequence the surgery was re-scheduled.Thus, the case was deemed reportable.
 
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Brand Name
HOPKINS TELESCOPE 6°, 18 FR.
Common Device Name
HOPKINS TELESCOPE 6°, 18 FR.
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key23865584
Report Number2020550-2025-02391
Device Sequence Number4618933
Product Code FGA
UDI-Device Identifier04048551233825
UDI-Public04048551233825
Combination Product (Y/N)N
Initial Reporter CountryIN
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) 12/22/2025
Report Date (Section F) 12/22/2025
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 Number27294AA
Device Catalogue Number27294AA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/08/2025
Event Location Hospital
Date Report to Manufacturer12/22/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/22/2025
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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