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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 Misfire (2532); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2020
Event Type  malfunction  
Event Description
From staff: during a robotically-assisted gastric sleeve procedure, the xi 60 sureform stapler jammed mid-staple. A second stapler was obtained, and the procedure was successfully completed using the second stapler. From op report: a 40 french bougie was passed trans-orally into the stomach. It was placed against the lesser curvature of the stomach. The major portion of the stomach was then removed with subsequent firing of the robotic stapler. An initial green load was used followed by subsequent firings of a blue load. With approximately 2 staple load fires remaining blue loaded stapler was placed in the position against the bougie. The stapler did not fire correctly. It appeared that a staple was stuck within the trach next to the blade causing s stable or to inaccurate early since the tissue. After a few cm the stapler was unclamped and was removed from the field. I inspected the area and was successfully able to come inside of this malfunction stable on against the boogie. Subsequent stable firings were then used to finish the transection. Manufacturer response for staple, implantable, sureform (per site reporter). Asked us to keep device for examination. Rep will ask to be shipped back at a later date. Manufacturer response for system, surgical, computer controlled instrument, sureform (per site reporter) manufacturer asked us to keep device for examination. They will request at a later date.
 
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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 Key10419535
MDR Text Key203299721
Report Number10419535
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874115640
UDI-Public(01)00886874115640
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480460
Device Lot NumberL91200322
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2020
Event Location Hospital
Date Report to Manufacturer08/18/2020
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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