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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON J&J HARMONIC SCALPEL EES GENERATOR

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ETHICON J&J HARMONIC SCALPEL EES GENERATOR Back to Search Results
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 09/15/2016
Event Type  Other  
Event Description
Harmonic scalpel used and placed on drape. Scrub personnel asked if instrument performing appropriately as had burn mark on drape where device was placed. Upon inspection of device was noted to have a plastic portion missing. Device was removed from the field and replaced. Damaged device was retained per protocol.
 
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Brand NameJ&J HARMONIC SCALPEL
Type of DeviceEES GENERATOR
Manufacturer (Section D)
ETHICON
route 22
west somerville NJ 08876
MDR Report Key6215315
MDR Text Key63727037
Report NumberMW5066980
Device Sequence Number1
Product Code HGI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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