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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST TENACULUM FORCEPS SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470207
Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2020
Event Type  malfunction  
Event Description
Robotic instrument broke during procedure, unable to remove from trocar. Entire trocar with instrument removed and replaced to finish procedure. The instrument was stuck in the obturator and then was not functional. When it was removed and 2nd instrument was used, it was successful. Instrument was reported to intuitive for malfunction. Clinical engineering went to sterile processing department (spd), the broken equipment wasn't there. Talked to director of surgery, she states this was disposable piece, it was trashed, and the company replaced it with a new one. It wasn't a problem with the davinci equipment itself. No further action required by clinical engineering.
 
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Brand NameENDOWRIST TENACULUM FORCEPS
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12057745
MDR Text Key258060479
Report Number12057745
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 Other Health Care Professional
Type of Report Initial
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number470207
Device Lot NumberN10191104-0042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2021
Event Location Hospital
Date Report to Manufacturer06/24/2021
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 Unkown

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