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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
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KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE Back to Search Results
Model Number 011050-01
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2023
Event Type  Injury  
Event Description
The following was reported: "as soon as they are introduced into the operating channel, the electrodes break or bend during resection.This results in lost time and the need for a new electrode." medical intervention was required in which they had to adapt their procedure in order to finish the surgery.
 
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).
 
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Brand Name
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
Type of Device
ELECTRODE, BIPOLAR
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key18305577
MDR Text Key330199858
Report Number2020550-2023-00394
Device Sequence Number1
Product Code FAS
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 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number011050-01
Device Catalogue Number011050-01
Device Lot NumberPM12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/08/2023
Event Location Hospital
Date Report to Manufacturer12/11/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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