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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 Entrapment of Device (1212); Failure to Fire (2610)
Patient Problem Insufficient Information (4580)
Event Date 05/04/2021
Event Type  malfunction  
Event Description
Narrative from staff: when attempting to fire a robotic sureform 60 stapler during a procedure, the monitor said that the "tissue was too thick". It then locked and had to be manually removed. Narrative from operative report: 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. The 2nd last staple firing be sureform stapler sensed thick tissue and did not completely fire. Stapler was manually removed. I evaluated the tissue in this area and felt a blue load was still most appropriate. New stapler was used a blue load was clamped over the tissue and fired without difficulty. When approaching the last fire an angle we were careful not to include the distal esophagus by completing our staple firing between the left crus of the diaphragm and the spleen. Next the staple line was over sewn in a continuous running fashion with a barbed 2-0 stratafix suture.
 
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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 Key11840942
MDR Text Key251150129
Report Number11840942
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 Other Health Care Professional
Type of Report Initial
Report Date 05/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480460
Device Catalogue Number480460
Device Lot NumberL93201026
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/2021
Event Location Hospital
Date Report to Manufacturer05/18/2021
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 Unkown

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