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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 11582M
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/19/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the during a sialoendoscopy a breakage occurred.Foreign material was left inside the patient.No harm to patient, user or third 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
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 Key21074386
Report Number2020550-2025-00013
Device Sequence Number8497811
Product Code GCJ
UDI-Device Identifier04048551051863
UDI-Public04048551051863
Combination Product (Y/N)N
Initial Reporter CountryAU
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) 01/03/2025
Report Date (Section F) 12/30/2024
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 Number11582M
Device Catalogue Number11582M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/19/2024
Event Location Hospital
Date Report to Manufacturer12/30/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/03/2025
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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