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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE; ELEKTRODE, BIPOLAR
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KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE; ELEKTRODE, BIPOLAR Back to Search Results
Model Number 011160-01
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)
Event Date 12/19/2023
Event Type  Injury  
Event Description
It was reported that the insufficiently definable coagulation effect was noticed a few days ago.Cutting sufficient, coagulation very weak.The same problem occurred during a tur.Vessels were cut, but no coagulation effect.Patient had massive blood loss and had to undergo an emergency radical prostatectomy.Due to the reported blood loss as well as the unplanned prostatectomy, this case is deemed reportable.
 
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
Type of Device
ELEKTRODE, BIPOLAR
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key18388584
MDR Text Key331291985
Report Number2020550-2023-00404
Device Sequence Number1
Product Code FAS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/22/2023
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 Number011160-01
Device Catalogue Number011160-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/21/2023
Event Location Hospital
Date Report to Manufacturer12/22/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/22/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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