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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE HARMONIC ACE

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INTUITIVE SURGICAL, INC NONE HARMONIC ACE Back to Search Results
Model Number 480275-08
Device Problems Break (1069); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
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Brand NameNONE
Type of DeviceHARMONIC ACE
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 Key14139070
Report Number2955842-2022-11131
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 03/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2021
Device Model Number480275-08
Device Catalogue Number480275
Device Lot NumberM90200324 0016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Date Manufacturer Received03/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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