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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE SURGICAL ROBOTIC EQUIPMENT DA VINCI ROBOTIC HOOK SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. INTUITIVE SURGICAL ROBOTIC EQUIPMENT DA VINCI ROBOTIC HOOK SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Lot Number N111810040097
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2019
Event Type  malfunction  
Event Description
Patient in surgery for robotic assisted cholecystectomy. Intuitive da vinci equipment used for surgery. Hook broke. No missing pieces noted upon removal of equipment. No harm to the patient.
 
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Brand NameINTUITIVE SURGICAL ROBOTIC EQUIPMENT DA VINCI ROBOTIC HOOK
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key8343866
MDR Text Key137120762
Report NumberMW5084132
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
Type of Report Initial
Report Date 02/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberN111810040097
Was Device Available for Evaluation? Yes
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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