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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DA VINCI XI STAPLER 45XI; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
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DA VINCI XI STAPLER 45XI; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number REF 470298
Device Problem Firing Problem (4011)
Patient Problem Blood Loss (2597)
Event Date 07/17/2019
Event Type  Injury  
Event Description
During the robotic assisted thorascopic upper lobectomy, following stapling of multiple arteries and veins with curved 30 xi stapler, the straight 45 xi stapler was inserted with blue staple load to transect the bronchus.The straight 45 xi stapler malfunction during the firing procedure.The warning said to remove the stapler out.The cartridge was removed and a new load was inserted but the same thing occurred.A new 45 xi stapler was obtained along with a new cartridge.Surgeon inserted the stapler and he noticed that the prior 2 attempts had cause some unnecessary bleeding.The bleeding was controlled and bronchus was successfully stapled.Fda safety report id# (b)(4).
 
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Brand Name
DA VINCI XI STAPLER 45XI
Type of Device
SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
MDR Report Key8843479
MDR Text Key153090684
Report NumberMW5088550
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112427
UDI-Public(01)00886874112427
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberREF 470298
Device Lot NumberT10180925-0009
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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