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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ IMAGING ASM,HEAD,IMAGE1 S,H3-ZA, CE
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KARL STORZ IMAGING ASM,HEAD,IMAGE1 S,H3-ZA, CE Back to Search Results
Model Number TH104
Medical Device Problem Code Erratic or Intermittent Display (1182)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/06/2026
Type of Reportable Event Malfunction
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Brand Name
ASM,HEAD,IMAGE1 S,H3-ZA, CE
Common Device Name
ASM,HEAD,IMAGE1 S,H3-ZA, CE
Manufacturer (Section D)
KARL STORZ IMAGING
1 s. los cameros road
goleta, ca 93117
GM  93117
Manufacturer (Section G)
KARL STORZ IMAGING
1 s. los cameros road
goleta, ca 93117
GM   93117
Manufacturer Contact
anja fair
2151 e grand ave
el segundo, CA 90245
MDR Report Key50105212
Report Number2027009-2026-01742
Device Sequence Number10077054
Product Code FET
UDI-Device Identifier04048551333969
UDI-Public04048551333969
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K131953
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional,User Facility,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/31/2026
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 NumberTH104
Device Catalogue NumberTH104
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/21/2026
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2026
Initial Report FDA Received Date07/31/2026
Was Device Evaluated by Manufacturer? (Y/N) No
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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