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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. MARYLAND BIPOLAR FORCEP DA VINCI XI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL INC. MARYLAND BIPOLAR FORCEP DA VINCI XI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470172
Device Problems Break (1069); Failure to Calibrate (2440)
Patient Problem No Information (3190)
Event Date 03/28/2018
Event Type  malfunction  
Event Description
Cable wire broke. Camera not calibrating.
 
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Brand NameMARYLAND BIPOLAR FORCEP DA VINCI XI
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
MDR Report Key7411574
MDR Text Key105163974
Report NumberMW5076395
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 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470172
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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?
Type of Device Usage

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