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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG S-PILOT
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KARL STORZ SE & CO. KG S-PILOT Back to Search Results
Model Number UP501
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/24/2025
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
The following was reported: at the start of surgery, the pinch valve of the product remained open, and attempts to turn the power on and off did not improve the situation.
 
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Brand Name
S-PILOT
Common Device Name
S-PILOT
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key22730201
Report Number2020550-2025-01381
Device Sequence Number8990107
Product Code GCX
UDI-Device Identifier04048551354155
UDI-Public04048551354155
Combination Product (Y/N)N
Initial Reporter CountryJA
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) 08/06/2025
Report Date (Section F) 08/06/2025
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 NumberUP501
Device Catalogue NumberUP501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/05/2025
Event Location Hospital
Date Report to Manufacturer08/06/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/06/2025
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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