MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT SELECT

Model Number	UP210
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	12/19/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Event or Problem Description
When the surgeon connected the tubing set 030647-10 to endomat select up210 and started using them, air got mixed in and the field of view became poor.At this time, water was being supplied, but suction was not sufficient.About 20 minutes after the start of the surgery, the patient's heart rate and blood pressure decreased and suddenly changed.An echocardiogram confirmed that air was entering the right atrium.

• Brand Name: ENDOMAT SELECT
• Common Device Name: ENDOMAT SELECT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18455754
• Report Number: 2020550-2024-00002
• Device Sequence Number: 16922784
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• 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): 01/05/2024
• Report Date (Section F): 01/05/2024

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: UP210
• Device Catalogue Number: UP210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 030647-10 TUBING SET, SUCTION
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown