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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST LARGE NEEDLE DRIVER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471006
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2021
Event Type  malfunction  
Event Description
The surgeon noted what appeared to be shards of the sheath of the large needle holder's sheath inside the pt's abdominal cavity. All visible pieces were carefully removed, and stat x-ray called. Read as negative for urfo (unintended retention of foreign objects). There was no alarm indication prior to when the pieces broke. Suggest checking if adjustments can be made to the robot alarm parameters to detect problems before sheath breaks.
 
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Brand NameENDOWRIST LARGE NEEDLE DRIVER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12158347
MDR Text Key261232079
Report Number12158347
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 06/30/2021,04/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471006
Device Lot NumberN102005250398
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/30/2021
Event Location Hospital
Date Report to Manufacturer07/13/2021
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? Yes
Type of Device Usage Unkown

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