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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS AMERICA OLYMPUS ES6-400 ELECTRO SURGICAL UNIT BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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OLYMPUS AMERICA OLYMPUS ES6-400 ELECTRO SURGICAL UNIT BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number WB910510
Device Problems Device Emits Odor (1425); Flare or Flash (2942)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2020
Event Type  malfunction  
Event Description
Pt was undergoing a cystoscopy for rule out bladder tumor.The physician was using the olympus bovie, attempting to cauterize in the bladder using a bugbee.The grounding pad light was flashing red/ green when md stepped on the foot pedal and no cautery was visible.Bovie pad was changed out.Cauterization was then visible but not efficient.All team members smelled "burning like an electrical fire".Md stopped cautery use, machine was disconnected from the patient, unplugged and removed from the operating room.Surgery to be completed correctly.Upon inspection there was brown discoloration with a burning smell.Pt returned electrode, ref e7507.
 
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Brand Name
OLYMPUS ES6-400 ELECTRO SURGICAL UNIT BOVIE
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
OLYMPUS AMERICA
3500 corporate pky
center valley PA 18034 0610
MDR Report Key10312092
MDR Text Key200208742
Report NumberMW5095670
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWB910510
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/22/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age87 YR
Patient Weight52
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