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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI XI MONOPOLAR CURVED SCISSORS

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INTUITIVE SURGICAL DA VINCI XI MONOPOLAR CURVED SCISSORS Back to Search Results
Model Number 470179
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/24/2017
Event Type  malfunction  
Event Description
Using davinci xi monopolar scissors and a piece of the plastic broke off of the instrument and into the patient. Plastic was retrieved from the abdomen. Instrument reference # 470179, ver -14 and lot # s10161130 0053.
 
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Brand NameDA VINCI XI
Type of DeviceMONOPOLAR CURVED SCISSORS
Manufacturer (Section D)
INTUITIVE SURGICAL
MDR Report Key6995774
MDR Text Key90942290
Report NumberMW5073079
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 10/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470179
Device Lot NumberS10161130 0053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2017
Is the Reporter a Health Professional? No Answer provided
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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