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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ROBOTIC VESSEL SEALER EXTENDED SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ROBOTIC VESSEL SEALER EXTENDED SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480422
Device Problems Break (1069); Material Frayed (1262)
Patient Problem Insufficient Information (4580)
Event Date 07/19/2021
Event Type  malfunction  
Event Description
After the uterus was removed from the patient the surgeon requested to exchange the robotic vessel seal extend for the prograsp instrument to suture/close the vaginal cuff. The primary scrub rn noticed the robotic vessel sealer extend wire/fiber was frayed and broken. The surgeon was notified about the broken instrument. No visible remnant of instrument was discovered in patient's abdomen or pelvis. The broken vessel sealer extend instrument was permanently removed from the case and was placed in red biohazard bag with patient sticker and vendor packaging. Another robotic bipolar instrument and cord was opened to the sterile field to complete the case. Fda safety report id # (b)(4).
 
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Brand NameROBOTIC VESSEL SEALER EXTENDED
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key12216936
MDR Text Key263381220
Report NumberMW5102724
Device Sequence Number1
Product Code NAY
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 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480422
Device Lot NumberL91210419
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? No
Type of Device Usage

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