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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CO2 HIGH PRESSURE TUBE, PIN-INDEX
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KARL STORZ SE & CO. KG CO2 HIGH PRESSURE TUBE, PIN-INDEX Back to Search Results
Model Number 20400028
Medical Device Problem Code Gas/Air Leak (2946)
Health Effect - Clinical Codes Discomfort (2330); Myocarditis (2470)
Date of Event 06/04/2024
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 that co2 gas was leaking from the hose yoke connection resulting in 3 members of staff feeling light headed and phoning 111 (national health service) for advice.
 
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Brand Name
CO2 HIGH PRESSURE TUBE, PIN-INDEX
Common Device Name
HIGH PRESSURE TUBE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key19558488
Report Number2020550-2024-00181
Device Sequence Number14655641
Product Code NKC
UDI-Device Identifier04048551067574
UDI-Public4048551067574
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 06/18/2024
Report Date (Section F) 06/18/2024
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 Number20400028
Device Catalogue Number20400028
Device Lot NumberYV01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/17/2024
Event Location Hospital
Date Report to Manufacturer06/18/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/18/2024
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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