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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BI-POLAR ELECTORDE
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KARL STORZ SE & CO. KG BI-POLAR ELECTORDE Back to Search Results
Model Number 011165-10
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2022
Event Type  malfunction  
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.
 
Event Description
The event occurred in canada.It was reported that the loop broke off inside the patient's bladder.No negative impact on the state of health was reported.The broken part was retrieved.Internal karl storz reference number: (b)(4).
 
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Brand Name
BI-POLAR ELECTORDE
Type of Device
BI-POLAR ELECTORDE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM   78532
Manufacturer Contact
anja fair
2151 e grand ave
el segundo, CA 90245-5017
4242188738
MDR Report Key15978992
MDR Text Key306978008
Report Number9610617-2022-00332
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551411087
UDI-Public4048551411087
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number011165-10
Device Catalogue Number011165-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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