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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL ROBOTIC GRASPER

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INTUITIVE SURGICAL ROBOTIC GRASPER Back to Search Results
Catalog Number 470400
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 01/02/2018
Event Type  malfunction  
Event Description
Small piece of the tip of the xl robotic long bipolar grasper came off and was found in the trocar at the end of the case-near miss.
 
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Brand NameROBOTIC GRASPER
Type of DeviceROBOTIC GRASPER
Manufacturer (Section D)
INTUITIVE SURGICAL
MDR Report Key7224603
MDR Text Key98533656
Report NumberMW5074930
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 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number470400
Device Lot NumberN1011040013
Was Device Available for Evaluation? No
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?
Type of Device Usage

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