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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
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KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE Back to Search Results
Model Number 011050-10
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2023
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 france.It was reported that when inserting the resector into the uterus, they tried to resect, and the metal tip of the disposable loop broke in the uterus, leaving a piece of a few millimeters that had to be removed.
 
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Brand Name
ELECTRODE, BIPOLAR
Type of Device
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key16748427
MDR Text Key313387853
Report Number2020550-2023-00078
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/13/2023,04/15/2023
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 Number011050-10
Device Catalogue Number011050-10
Device Lot Number841338
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/13/2023
Event Location Hospital
Date Report to Manufacturer04/13/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/15/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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