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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY SYNCHROSEAL

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INTUITIVE SURGICAL, INC DA VINCI ENERGY SYNCHROSEAL Back to Search Results
Model Number 480440-05
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
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Brand NameDA VINCI ENERGY
Type of DeviceSYNCHROSEAL
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 Key13913483
Report Number2955842-2022-10804
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K191280
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 03/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/07/2021
Device Model Number480440-05
Device Catalogue Number480440
Device Lot NumberL90210617 0049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2022
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2021
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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