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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 Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2018
Event Type  malfunction  
Event Description
On introduction of the stapler, that was not connected to tissue - the stapler locked and the surgeon was unable to move stapler.The dial on top was turned to "engage and release." then 2 buttons on the side were used to aid in the release.The stapler was removed without any issue.
 
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Brand Name
SUREFORM
Type of Device
SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
building 101
sunnyvale CA 94086 5304
MDR Report Key8132429
MDR Text Key129354936
Report Number8132429
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 Nurse
Type of Report Initial
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number480460
Device Lot NumberT10180821
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2018
Event Location Hospital
Date Report to Manufacturer12/05/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age22995 DA
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