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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SI STAPLER 45; DA VINCI STAPLER 45
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INTUITIVE SURGICAL, INC. DA VINCI SI STAPLER 45; DA VINCI STAPLER 45 Back to Search Results
Lot Number S10161202397
Device Problems Unknown (for use when the device problem is not known) (2204); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
Event Type  Injury  
Event Description
Reported from operating room that the patient was having a robotic-assisted laparoscopic low anterior resection of the rectum and the davinci robot 45 stapler jammed while attached to tissue and would not release.Even with the use of the emergency unlocking key.Instrument would not release tissue intracavity.Davinci troubleshooting was called and the staff had to pry the stapler head open very carefully to release the tissue.No harm occurred as a result.In the report another type of stapler was used to complete the procedure.
 
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Brand Name
DA VINCI SI STAPLER 45
Type of Device
DA VINCI STAPLER 45
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1020 kifer rd.
sunnyvale CA 94086
MDR Report Key7240886
MDR Text Key99122683
Report Number7240886
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberS10161202397
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/23/2018
Distributor Facility Aware Date01/16/2018
Event Location Hospital
Date Report to Manufacturer01/23/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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