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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480322
Device Problems Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2017
Event Type  malfunction  
Event Description
Robotic vessel sealer stopped working. Blades didn't retract back into patient. Procedure: robotic total hysterectomy, bilateral salpingo-oophorectomy, lysis of adhesions. Disposable unit was not being used correctly and was safely removed from patient and there was no injury to patient. Another unit was provided and worked fine. Circulating nurse should have worded incident report comments to say something along the lines of, ". The blade would not retract back into instrument sheath. ".
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd.
sunnyvale CA 94086
MDR Report Key7005890
MDR Text Key91224483
Report Number7005890
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480322
Device Lot NumberM1017045
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 FDA10/19/2017
Event Location Hospital
Date Report to Manufacturer10/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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