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

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
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.
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).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.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
According to the ifu, the hose must be replaced after 5 years.The hose of this report is, according to the lot number, manufactured in august 2011.This means, the lifetime of the hose is expired for 8 years.Further, the customer was using a wrong sealing between the high-pressure hose and the co2 cylinder.This could also lead to the described issue of leaking gas.The root cause for this incident is use error and/or wearing.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Information was corrected is provided in section g3 to reflect that the correct aware date from the last supplemental report.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section h6 to add a component code.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• 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: 19558492
• Report Number: 9610617-2024-00181
• Device Sequence Number: 11945647
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/20/2024

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: YV01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 08/14/2024; 08/12/2024; 08/12/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/10/2024; 08/21/2024; 08/21/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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