MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CO2 HIGH PRESSURE TUBE, PIN-INDEX

Model Number	20400028
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/21/2024
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 a nurse received a gas burn to their hand while changing the co2 bottle.
Additional Manufacturer Narrative
Additional information is provided in section b3 to provide the event date.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The product was not returned to karl storz tuttlingen.Based on the customer description, it can be assumed that the user is at fault.The sudden release of co2 can lead to cold burns.The cause of the leakage could be that the connection was not fitted correctly when the cylinder was changed, allowing gas to escape, or that the hose was no longer tight and gas could escape from a hole in the hose when the cylinder was unscrewed.As the article has not been returned, a more detailed examination cannot be carried out.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CO2 HIGH PRESSURE TUBE, PIN-INDEX
• Common Device Name: CO2 HIGH PRESSURE TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 19628921
• Report Number: 9610617-2024-00186
• Device Sequence Number: 7065400
• Product Code: NKC
• UDI-Device Identifier: 04048551067574
• UDI-Public: 4048551067574
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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 Number: 20400028
• Device Catalogue Number: 20400028
• Device Lot Number: UV01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 08/05/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/30/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown