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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. STAPLER 30 CURVED TIP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL INC. STAPLER 30 CURVED TIP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470530
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/24/2018
Event Type  malfunction  
Event Description
This stapler was being used during a robotic case, and when the surgeon asked for it to be removed from the trocar within the pt, the handpiece would not release from the robotic carrier/arm. The buttons on the handpiece did not appear to work. The stapler release kit was opened and used to no avail. After several attempts to remove the handpiece from the robotic arm, the surgical tech was able to remove it with force. The stapler was not clamped on the pt's tissue at the time, and the pt was not injured during this time. Devices will be returned only if mfr provides prepaid shipping, packaging as per dot, or pick the item up. The details in the report is the extent to which we identify medications involved or pt contact.
 
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Brand NameSTAPLER 30 CURVED TIP
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
MDR Report Key7885220
MDR Text Key120826936
Report NumberMW5079858
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 Non-Healthcare Professional
Type of Report Initial
Report Date 09/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470530
Device Lot NumberS10170307 0014
Was Device Available for Evaluation? Yes
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? No
Type of Device Usage

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