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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. TIP-UP FENESTRATED GRASPER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. TIP-UP FENESTRATED GRASPER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI-8MM
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2020
Event Type  Injury  
Event Description
At end of robotic thoracoscopy for upper lobectomy. Md was unable to pull instrument out of fourth robotic arm as it was stuck at a 90 degrees angle inside the patient. A laparoscopic davis and geck was used by the surgeon to straighten the instrument somewhat and the whole trocar and instrument were removed from the patients abdomen at the same time. Instrument was then removed from robot arm. Instrument information tip-up fenestrated grasper xi-8mm ref # (b)(4). Fda safety report id # (b)(4).
 
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Brand NameTIP-UP FENESTRATED GRASPER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key9693783
MDR Text Key179101870
Report NumberMW5092893
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 Risk Manager
Type of Report Initial
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXI-8MM
Device Lot NumberN101906110059
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 02/10/2020 Patient Sequence Number: 1
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