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

Model Number UP210

Device Problem Infusion or Flow Problem (2964)

Patient Problem 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).

• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 18455749
• MDR Text Key: 332205550
• Report Number: 9610617-2024-00003
• Device Sequence Number: 1
• Product Code: HIG
• 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
• Report Date: 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
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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