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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
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KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE Back to Search Results
Model Number 011160-10
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 10/06/2023
Event Type  Injury  
Event Description
It was reported that loop electrode broke inside patient.According to this information and a lack of information for the patient outcome the case is deemed reportable.
 
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
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key18004549
MDR Text Key326502252
Report Number2020550-2023-00311
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551411087
UDI-Public4048551411087
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 10/25/2023
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 Number011160-10
Device Catalogue Number011160-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/25/2023
Event Location Hospital
Date Report to Manufacturer10/25/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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