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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI INC. GYRUS PK BUTTON FRONT LOADING ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

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GYRUS ACMI INC. GYRUS PK BUTTON FRONT LOADING ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL Back to Search Results
Model Number 786500
Device Problems Smoking (1585); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 11/23/2015
Event Type  malfunction  
Event Description
Surgeon completed using the device and noticed that it was smoking.After removal from the field and disassembly there was black soot noticed on the cable and disposable device.
 
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Brand Name
GYRUS PK BUTTON FRONT LOADING ELECTRODE
Type of Device
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Manufacturer (Section D)
GYRUS ACMI INC.
135 turnpike road
southborough MA 01772
MDR Report Key5292440
MDR Text Key33365314
Report Number5292440
Device Sequence Number1
Product Code FAS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/07/2015
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
Device Operator Physician
Device Expiration Date07/31/2018
Device Model Number786500
Device Lot NumberU1508019
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2015
Event Location Hospital
Date Report to Manufacturer12/07/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/14/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age69 YR
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