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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVINCI XI ENDO WRIST STAPLER 45 SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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DAVINCI XI ENDO WRIST STAPLER 45 SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI STAPLER
Device Problems Device Alarm System (1012); Difficult to Remove (1528); Failure to Calibrate (2440); Difficult to Open or Close (2921)
Patient Problem No Information (3190)
Event Date 01/22/2019
Event Type  malfunction  
Event Description
During a low anterior bowel resection, the intuitive xl stapler malfunctioned. Stapler would not calibrate upon insertion. Stapler was removed, connections cleaned sterile connection plate removed and re attached. Stapler re inserted and would not calibrate over 69%. Stapler removed from robot. Stapler jaw would not open. Manuel key would not open jaw. Stapler removed from service. Remaining lives left on device(44/50 remaining). Stapler load was unable to be removed. Intuitive surgical, inc. , (b)(4).
 
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Brand NameDAVINCI XI ENDO WRIST STAPLER 45
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
MDR Report Key8281632
MDR Text Key134571580
Report NumberMW5083418
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXI STAPLER
Device Catalogue Number470298
Device Lot NumberT10181017 003
Was Device Available for Evaluation? Yes
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 01/25/2019 Patient Sequence Number: 1
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