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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. BIPOLAR HIGH FREQUENCY CORD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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KARL STORZ ENDOSCOPY-AMERICA, INC. BIPOLAR HIGH FREQUENCY CORD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number UH801
Device Problem Thermal Decomposition of Device (1071)
Patient Problem Insufficient Information (4580)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
Operating room staff noted a burn mark on the karl storz high frequency bipolar cord (uh801) upon completion of the urology procedure.The burn mark was located on the cord where the electrode connects to the cord.This was the 2nd instance of staff noting a burn mark on a karl storz uh801 bipolar cord following the completion of a procedure.Manufacturer response for high frequency bipolar cord, (brand not provided) (per site reporter) the karl storz rep was notified of the issue stating these cords should be replaced every 90 days.(these cords cost between (b)(6) each to replace.).
 
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Brand Name
BIPOLAR HIGH FREQUENCY CORD
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e grand avenue
el segundo CA 90245
MDR Report Key15239668
MDR Text Key298044447
Report Number15239668
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUH801
Device Catalogue NumberUH801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/09/2022
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer08/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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