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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE DA VINCI LARGE SUTURECUT N. DRIVE (XI) SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE DA VINCI LARGE SUTURECUT N. DRIVE (XI) SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number DA VINCI XI
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2017
Event Type  malfunction  
Event Description
This intuitive instrument was returned to me with a note stating "frayed cable". No other details were noted as to whether this occurred during the case or after processing. There were 9 lives remaining on the instrument at the conclusion of the case on the date noted above. There was no harm to the patient indicated, and the case was completed as planned.
 
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Brand NameDA VINCI LARGE SUTURECUT N. DRIVE (XI)
Type of DeviceSYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE
sunnyvale CA 94086
MDR Report Key7420946
MDR Text Key105379192
Report NumberMW5076403
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 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDA VINCI XI
Device Catalogue NumberREF # 470296 VER04
Device Lot NumberN10171102 0026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
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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