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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI XI VISION SIDE SYSTEM Back to Search Results
Model Number 381121-28
Device Problem Poor Quality Image (1408)
Event Date 02/14/2022
Event Type  malfunction  
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Brand NameDAVINCI XI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13765561
Report Number2955842-2022-10607
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Report Date 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381121-28
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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