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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI ROBOT PROGRASP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DA VINCI XI ROBOT PROGRASP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Lot Number N112103010392
Device Problems Entrapment of Device (1212); Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 07/15/2021
Event Type  Injury  
Event Description
Prograsp instrument had a fractured wire in its cable system. Fda safety report id # (b)(4).
 
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Brand NameDA VINCI XI ROBOT PROGRASP
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key12210761
MDR Text Key263154914
Report NumberMW5102705
Device Sequence Number1
Product Code NAY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot NumberN112103010392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
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?
Type of Device Usage

Patient Treatment Data
Date Received: 07/21/2021 Patient Sequence Number: 1
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