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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SUCTION IRRIGATOR SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DA VINCI SUCTION IRRIGATOR SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Description
The tip of the da vinci xi irrigator bent while in use and was not able to be removed from the trocar while case was in progress. This occurred at the end of the case. The surgeon scrubbed back in and had to totally remove the trocar from the pt's abdomen. Since it was the end of the case, all instruments and trocars were removed and closure began. No harm was done to the pt. Fda safety report id# (b)(4).
 
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Brand NameDA VINCI SUCTION IRRIGATOR
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale 84086
MDR Report Key13118701
MDR Text Key283175923
Report NumberMW5106384
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 12/28/2021
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? No
Device Operator
Device Model NumberXI
Device Catalogue Number480299
Device Lot NumberM10210720
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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