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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE INTUITIVE VESSEL SEALER

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INTUITIVE INTUITIVE VESSEL SEALER Back to Search Results
Lot Number M10160804
Device Problems Failure of Device to Self-Test (2937); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2016
Event Type  malfunction  
Event Description
Prior to starting the case, the vessel sealer was placed in arm #1 and the vessel sealer failed to self check.Instrument was removed and it was noted the blade was exposed.No harm to the patient.Diagnosis or reason for use: pelvic pain.Event abated after use stopped or dose reduced: yes.
 
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Brand Name
INTUITIVE VESSEL SEALER
Type of Device
VESSEL SEALER
Manufacturer (Section D)
INTUITIVE
sunnyvale CA
MDR Report Key6410611
MDR Text Key70187890
Report NumberMW5068497
Device Sequence Number1
Product Code NAY
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 10/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberM10160804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2016
Is the Reporter a Health Professional? Yes
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 Age72 YR
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