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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number 420172-17
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 03/09/2022
Event Type  Injury  
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceMARYLAND BIPOLAR FORCEPS
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 Key14058094
Report Number2955842-2022-10949
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/09/2022
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 Number420172-17
Device Catalogue Number420172
Device Lot NumberN10210719 474
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
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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