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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 5 MM, 29 CM

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KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 5 MM, 29 CM Back to Search Results
Model Number R26046BA
Medical Device Problem Codes Dent in Material (2526); Chemical Problem (2893); Material Deformation (2976); Optical Problem (3001); Scratched Material (3020)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
 
Event or Problem Description
It was reported that the lens is hazy.No negative impact in state of health reported.
 
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Brand Name
HOPKINS TELESCOPE 30°, 5 MM, 29 CM
Common Device Name
HOPKINS TELESCOPE 30°, 5 MM, 29 CM
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen 78532
GM  78532
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen 78532
GM   78532
Manufacturer Contact
anja fair
2151 e grand ave
el segundo, CA 90245
4242188247
MDR Report Key24593687
Report Number9610617-2026-00441
Device Sequence Number10391291
Product Code GCJ
UDI-Device Identifier04048551092132
UDI-Public04048551092132
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K935279
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,User Facility,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/25/2026
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 NumberR26046BA
Device Catalogue NumberR26046BA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2026
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2026
Supplement Date Received by Manufacturer06/22/2026
Initial Report FDA Received Date03/13/2026
Supplement Report FDA Received Date06/25/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
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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