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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1 S H3-Z FI; TH102
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KARL STORZ IMAGING IMAGE1 S H3-Z FI; TH102 Back to Search Results
Model Number TH102
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/16/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the system reports incompatible camera head.The patient was already sedated and the surgery had to be canceled.No negative impact in state of health reported.
 
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
IMAGE1 S H3-Z FI
Common Device Name
TH102
Manufacturer (Section D)
KARL STORZ IMAGING
1 s. los carneros road
goleta CA 93117
MDR Report Key21103857
Report Number2020550-2025-00009
Device Sequence Number13041012
Product Code OWN
UDI-Device Identifier04048551333150
UDI-Public04048551333150
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 01/08/2025
Report Date (Section F) 01/08/2025
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 NumberTH102
Device Catalogue NumberTH102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/16/2024
Event Location Hospital
Date Report to Manufacturer01/08/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/08/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
TC200 IMAGE1 S CONNECT.; TC300 IMAGE1 S H3-LINK.
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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