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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE
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KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE Back to Search Results
Model Number 011161-10
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 04/05/2024
Event Type  Injury  
Event Description
It was reported that during the resection of the fibroid the cutting loop snapped off.The piece fell into patient.X-ray was taken but the piece wasn't found.Due to the potential fragment in situ the case is reportable as a precautionary measure.
 
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
 
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Brand Name
ENDOSCOPIC ELECTROSURGICAL ELECTRODE
Type of Device
ELECTRODE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key19154520
MDR Text Key340734725
Report Number2020550-2024-00117
Device Sequence Number1
Product Code FAS
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 04/22/2024
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 Number011161-10
Device Catalogue Number011161-10
Device Lot Number842998
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/19/2024
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer04/22/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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