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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 61872 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
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KARL STORZ SE & CO. KG 61872 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE Back to Search Results
Model Number 011050-10
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/03/2023
Event Type  Injury  
Manufacturer Narrative
The importer number was incorrect in the last submission.This mdr contains the correct routing number.The event is filed under internal karl storz complaint id: (b)(4).
 
Event Description
According to the complaint description the device broke during use whilst trying to remove large fibroid.Piece is still inside patient and they are trying to remove from patient.The broken part is still in patient and a additional/prolonged hospitalization was necessary.
 
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Brand Name
61872 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 Key18185209
MDR Text Key328703682
Report Number2020550-2023-00376
Device Sequence Number1
Product Code HIH
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 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
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 Number847099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/16/2023
Event Location Hospital
Date Report to Manufacturer11/21/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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