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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. DA VINCI ENERGY SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480440
Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 01/14/2022
Event Type  malfunction  
Event Description
Patient was undergoing a robotic assisted laparoscopic right native nephrectomy. The surgeon used an 8mm synchroseal cautery/ligation device. When the device was removed from the patient, it was noted to be missing a section of the grasper housing. The provider searched inside the patient for the fragment and an x-ray was taken. The x-ray did not identify any foreign matter, but the radiologist noted plastic would not show up on x-ray.
 
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Brand NameDA VINCI ENERGY
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key13288566
MDR Text Key284007021
Report Number13288566
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480440
Device Catalogue Number480440
Device Lot NumberL91210921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2022
Event Location Hospital
Date Report to Manufacturer01/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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