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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 07/27/2023
Event Type  Injury  
Event Description
It was reported that the end of the electrode bipolar cutting loop snapped off and went into the patient's bladder while the surgeon was carrying out a turp.The surgery was prolonged for approximately half an hour as the surgeon had to retrieve the broken part of the loop before continuing with the operation.The broken part was retrieved.
 
Manufacturer Narrative
The suspected device is pending return for evaluation.Once the device is returned and evaluation is completed, a supplemental report will be made.The event is filed under internal karl storz complaint id: (b)(6).
 
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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 Key17549108
MDR Text Key321220746
Report Number2020550-2023-00209
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
Type of Report Initial
Report Date 08/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2023
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
Device Lot NumberPM61
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/15/2023
Distributor Facility Aware Date08/11/2023
Event Location Hospital
Date Report to Manufacturer08/15/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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