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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. SUREFORM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480460
Device Problems Failure to Calibrate (2440); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Event Description
During a gastric stapling robotic xi, robotic gastric sleeve with paraesophageal hernia repair, the sureform 60 12mm robotic stapler miss-fired-fired with two green loads and, then, would not calibrate. Surgeon attempted to troubleshoot the issue. Ultimately, another stapler had to be used. There was no harm to the patient.
 
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Brand NameSUREFORM
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key9871637
MDR Text Key184659970
Report Number9871637
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480460
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/20/2020
Event Location No Information
Date Report to Manufacturer03/24/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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