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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR WORKING ELEMENT; BIPOLAR RESECTOSCOPE
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KARL STORZ SE & CO. KG BIPOLAR WORKING ELEMENT; BIPOLAR RESECTOSCOPE Back to Search Results
Model Number 27040EB
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Burn, Thermal (2530)
Date of Event 11/30/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.
 
Event or Problem Description
We were served with a legal document, respondents in discovery, for a lawsuit against two facilities.The complaint indicated the patient underwent a cystoscopy with urethral dilation, transurethral resection/ablation of prostate with "button type bipolar prostate resector" and allegedly suffered thermal injury to his bladder and urethra.
 
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Brand Name
BIPOLAR WORKING ELEMENT
Common Device Name
BIPOLAR RESECTOSCOPE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
MDR Report Key8177027
Report Number9610617-2018-00098
Device Sequence Number1587994
Product Code FAS
UDI-Device Identifier04048551075623
UDI-Public4048551075623
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K061541
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/12/2018
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? No
Operator of Device Health Professional
Device Model Number27040EB
Device Catalogue Number27040EB
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2018
Initial Report FDA Received Date12/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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