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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT SELECT; SURGICAL IRRIGATION/ASPIRATION PUMP
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KARL STORZ SE & CO. KG ENDOMAT SELECT; SURGICAL IRRIGATION/ASPIRATION PUMP Back to Search Results
Model Number UP210
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2023
Event Type  Injury  
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
Event Description
The event occurred in great britain.It was reported that the stopcock on the sheath leaked during use and the pump stopped working during surgery.There was a prolongation of 1 hour and they had to convert to a mini-laparotomy (open surgery) to remove the prostate.
 
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Brand Name
ENDOMAT SELECT
Type of Device
SURGICAL IRRIGATION/ASPIRATION PUMP
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key17004246
MDR Text Key315994315
Report Number2020550-2023-00111
Device Sequence Number1
Product Code HIG
UDI-Device Identifier04048551376041
UDI-Public4048551376041
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/25/2023
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
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer05/25/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/25/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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