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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT SELECT
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KARL STORZ SE & CO. KG ENDOMAT SELECT Back to Search Results
Model Number UP210
Device Problem Infusion or Flow Problem (2964)
Patient Problem Unspecified Heart Problem (4454)
Event Date 12/19/2023
Event Type  Death  
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 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.
 
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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
MDR Report Key18455754
MDR Text Key332205532
Report Number2020550-2024-00002
Device Sequence Number1
Product Code HIG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
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
Date FDA Received01/05/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUP210
Device Catalogue NumberUP210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/04/2024
Event Location Hospital
Date Report to Manufacturer01/05/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
030647-10 TUBING SET, SUCTION
Patient Outcome(s) Death;
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