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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE EXTRACTOR, 0.4 MM, 4 WIRES
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KARL STORZ SE & CO. KG STONE EXTRACTOR, 0.4 MM, 4 WIRES Back to Search Results
Model Number 11573M
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Hemorrhage/Blood Loss/Bleeding (1888); Salivary Gland Problem (4484)
Date of Event 02/19/2025
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 when removing the salivary duct stone, the collection basket broke off.The salivary duct had to be opened.Bleeding occurred and the duration of the operation doubled.
 
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Brand Name
STONE EXTRACTOR, 0.4 MM, 4 WIRES
Common Device Name
STONE EXTRACTOR, 0.4 MM, 4 WIRES
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key21595094
Report Number2020550-2025-00429
Device Sequence Number12981201
Product Code GCJ
UDI-Device Identifier04048551276938
UDI-Public04048551276938
Combination Product (Y/N)N
Initial Reporter CountrySZ
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) 03/13/2025
Report Date (Section F) 03/13/2025
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 Number11573M
Device Catalogue Number11573M
Device Lot Number014125010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/07/2025
Event Location Hospital
Date Report to Manufacturer03/13/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/13/2025
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; Required Intervention;
Patient SexUnknown
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