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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 MARYLAND BIPOLAR FORCEPS

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INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC. DA VINCI SI MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number DA VINCI SI
Device Problem Stretched (1601)
Patient Problem No Patient Involvement (2645)
Event Date 12/26/2017
Event Type  malfunction  
Event Description
Black energy cable identified "stretched" out of its normal position. Taken out of service and returned to vendor.
 
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Brand NameINTUITIVE SURGICAL INC.
Type of DeviceDA VINCI SI MARYLAND BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
950 kifer rd.
sunnyvale CA 94086
MDR Report Key7194012
MDR Text Key97491263
Report NumberMW5074583
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 01/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDA VINCI SI
Device Catalogue Number420172-14
Device Lot NumberN10170821
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2018
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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