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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 Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2024
Event Type  Injury  
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
It was reported that the endomat select didn't have adequate suction during a procedure.The procedure could not be continued and the case was suspended.No death or (unanticipated) serious deterioration in state of health reported.Since the surgery was suspended, the case is deemed as reportable.
 
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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 Key18857846
MDR Text Key337127652
Report Number2020550-2024-00060
Device Sequence Number1
Product Code HIG
UDI-Device Identifier04048551376041
UDI-Public4048551376041
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/07/2024
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 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 Date03/06/2024
Event Location Hospital
Date Report to Manufacturer03/07/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/07/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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