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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP PATIENT SIDE CART

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INTUITIVE SURGICAL, INC DA VINCI SP PATIENT SIDE CART Back to Search Results
Model Number 380601
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure to Anastomose (1028); Hematoma (1884); Pain (1994)
Event Date 08/27/2021
Event Type  Injury  
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Brand NameDA VINCI SP
Type of DevicePATIENT SIDE CART
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 Key14063383
Report Number2955842-2022-10960
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380601
Device Catalogue Number380601
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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