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

Model Number UP210

Device Problems Infusion or Flow Problem (2964); Lack of Effect (4065)

Patient Problems Unspecified Vascular Problem (4441); Unspecified Heart Problem (4454)

Event Date 12/19/2023

Event Type  Death  

Event 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.

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).

Manufacturer Narrative

This supplemental report was created to provide the missing information from the last submitted report.The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.Result of investigation: according to the evaluation results (dated 2024-02-21) the devices and the tubing kit were not made available to karl storz for investigation.Based on the log files sent in, no malfunctions with the devices could be detected.During this procedure, high pressures were detected several times at which the device issued visual and acoustic warnings.As the products were not made available to karl storz, only the log files can be used for analysis.No device error can be detected here.The pressure was far too high for a long time.Therefore, the most probable root cause is a user error.No corrective actions necessary as there is no critical and/or systematic deviation found during investigation the current issue did not trigger the capa.The customer's attention was drawn to pages 47/48 and 55 of the ifu (mqs390_en_v1.0_03-2021_ifu_ce-mdr) to pay attention of venting the tubing system and alarm signals.It was no product related malfunction.Internal karl storz reference number: (b)(4).

• Brand Name: ENDOMAT SELECT
• Type of Device: ENDOMAT SELECT
• 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: anya fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 18455689
• MDR Text Key: 332205176
• Report Number: 9610617-2024-00002
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Model Number: UP210
• Device Catalogue Number: UP210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 12/21/2023; 04/08/2024
• Supplement Dates FDA Received: 02/26/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 030647-10 TUBING SET, SUCTION.
• Patient Outcome(s): Death