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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 470179
Device Problems Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Event Date 02/05/2020
Event Type  malfunction  
Event Description
Instrument got stuck in arm, had to pry out with meostat, wheel broken upon removal - 2 lives left.Manufacturer response for monopolar curved scissors, xi/x monopolar curved scissors (per site reporter).Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint "wheel broke upon removal." the instrument was found to have an input disk broken.Input disk 7 was found completely detached from the base of the housing.Improper cleaning during reprocessing most commonly causes this failure.
 
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Brand Name
ENDOWRIST
Type of Device
SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key9928207
MDR Text Key186539821
Report Number9928207
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 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number470179
Device Lot NumberN12190708(0222)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/10/2020
Event Location Hospital
Date Report to Manufacturer04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age10585 DA
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