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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC. DA VINCI SI ENDOWRIST STAPLER 45

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INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC. DA VINCI SI ENDOWRIST STAPLER 45 Back to Search Results
Model Number DA VINCI SI
Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2017
Event Type  Other  
Event Description
Cable became unattached from cam causing stapler to no longer function. Broken "pivot pin" on grip cables. No pt harm.
 
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Brand NameINTUITIVE SURGICAL INC.
Type of DeviceDA VINCI SI ENDOWRIST STAPLER 45
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
950 kifer road
sunnyvale CA 94086
MDR Report Key7104608
MDR Text Key94496150
Report NumberMW5073888
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberDA VINCI SI
Device Catalogue Number410298-10
Device Lot NumberS10150402-184
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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