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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°
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KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6° Back to Search Results
Model Number 27293AA
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/04/2025
Type of Reportable Event Serious Injury
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).
 
Event or Problem Description
It was reported that vision was lost during a surgery.The intervention was delayed 45 minutes.The patient didn't suffer any harm, and the surgery was finished accordingly.No negative impact in state of health reported.
 
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Brand Name
HOPKINS TELESCOPE 6°
Common Device Name
HOPKINS TELESCOPE 6°
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key21649189
Report Number2020550-2025-00472
Device Sequence Number7536413
Product Code FGA
UDI-Device Identifier04048551233795
UDI-Public04048551233795
Combination Product (Y/N)N
Initial Reporter CountrySP
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) 03/19/2025
Report Date (Section F) 03/19/2025
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 Number27293AA
Device Catalogue Number27293AA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/05/2025
Event Location Hospital
Date Report to Manufacturer03/19/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/19/2025
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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