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

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.

• Brand Name: SUREFORM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 11840942
• MDR Text Key: 251150129
• Report Number: 11840942
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460
• Device Catalogue Number: 480460
• Device Lot Number: L93201026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 98