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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI MEGA SUTURECUT NEEDLE DRIVER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DA VINCI MEGA SUTURECUT NEEDLE DRIVER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI
Device Problem Dull, Blunt (2407)
Patient Problem Insufficient Information (4580)
Event Date 12/22/2021
Event Type  malfunction  
Event Description
Robotic instrument, mega suture cut needle driver is dull after 5/15 uses and is not cutting suture; 10 lives remain on this instrument. I will return to intuitive for a reimbursement for remaining lives. Fda safety report id# (b)(4).
 
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Brand NameDA VINCI MEGA SUTURECUT NEEDLE DRIVER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key13118125
MDR Text Key283094093
Report NumberMW5106363
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXI
Device Catalogue Number471309
Device Lot NumberK10210329 0183
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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