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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SURGICAL XI SYSTEM ROBOT ARM USM2 SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DA VINCI SURGICAL XI SYSTEM ROBOT ARM USM2 SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 380647-25
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2020
Event Type  malfunction  
Event Description
During the patient's surgery, one of the arms malfunctioned alarmed a nonrecoverable fault. Multiple attempts were made to fix the problem without success. A different arm was used to continue the case. No patient harm. Intuitive rep present during case. Model xi. This is malfunctioned arm usm2 ¿ arm part number 380647-25.
 
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Brand NameDA VINCI SURGICAL XI SYSTEM ROBOT ARM USM2
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key10282190
MDR Text Key199070919
Report Number10282190
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380647-25
Device Catalogue Number380647-25
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/14/2020
Event Location Hospital
Date Report to Manufacturer07/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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