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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND

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INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND Back to Search Results
Model Number 480422-01
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
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Brand NameENDOWRIST
Type of DeviceVESSEL SEALER EXTEND
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 Key14054360
Report Number2955842-2022-10944
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Non-Healthcare Professional
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480422-01
Device Catalogue Number480422
Device Lot NumberL90220130 0078
Was Device Available for Evaluation? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2022
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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