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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 470545
Device Problem Entrapment of Device (1212)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2020
Event Type  malfunction  
Event Description
The surgeon was using the robot stapler instruments. During one part of the procedure, he decided to change stapler sizes, switching from a 45 to a 30. The 45 was in the patient at this time. During the process of removing the instrument from the patient and robot to switch, the 45 stapler would not come off of the robot. The assisting surgeon, physician's assistant, and scrub tech all tried to remove the instrument, but it stayed stuck in position while inside the patient, even after using the robot key that removes stuck instruments. (b)(6) support was called and was helping with trying to remove instrument. After some time, the scrub tech was able to remove the instrument.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key10413038
MDR Text Key203124022
Report Number10413038
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
Type of Report Initial
Report Date 08/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470545
Device Catalogue Number470545
Device Lot NumberT111810030010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/2020
Event Location Hospital
Date Report to Manufacturer08/17/2020
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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