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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 011160-01
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2023
Event Type  Injury  
Event Description
It was reported that there was a rupture of the loop during adenoma resection after bipolar enucleation.Consequence: extraction of the broken piece and prolongation of surgical time.It was furthermore confirmed that the procedure was completed successfully and there were no adverse consequences for the patient.However, a medical/ surgical/ diagnostical intervention was required and the surgery was prolonged between 15 and 60 minutes.
 
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
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 Key18536473
MDR Text Key333154199
Report Number2020550-2024-00012
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 01/17/2024,01/18/2024
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 Number011160-01
Device Catalogue Number011160-01
Device Lot NumberZN22
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/16/2024
Event Location Hospital
Date Report to Manufacturer01/17/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/18/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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