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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS NEPTUNE SMOKE EVACUATION PENCIL ; APPARATUS, EXHAUST, SURGICAL

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STRYKER INSTRUMENTS NEPTUNE SMOKE EVACUATION PENCIL ; APPARATUS, EXHAUST, SURGICAL Back to Search Results
Catalog Number 0703-047-000
Device Problems Melted (1385); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2020
Event Type  Injury  
Event Description
On (b)(6) 2020 pt was taken to the operating room for a cesarean section to deliver twin gestation (b)(6) weeks 5 days.The subcutaneous tissue was mitigated and small bleeders cauterized with the neptune smoke evacuation pencil.The tip of the equipment started to melt.On 02/21/2020 inspection of the valleylab force fx electrosurgical unit, biomet id#sl-n0322773, serial # (b)(4), se# (b)(4) was tested, outputs were found to be within normal spec using bc group esu-2300 electrosurgical analyzer.Fda safety report id# (b)(4).
 
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Brand Name
NEPTUNE SMOKE EVACUATION PENCIL
Type of Device
APPARATUS, EXHAUST, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS
kalamazoo MI
MDR Report Key9834854
MDR Text Key183796771
Report NumberMW5093761
Device Sequence Number1
Product Code FYD
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 03/12/2020
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 Expiration Date07/18/2022
Device Catalogue Number0703-047-000
Device Lot Number1934001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/13/2020
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 Outcome(s) Required Intervention;
Patient Age23 YR
Patient Weight71
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