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

Catalog Number 480460

Device Problems Connection Problem (2900); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

During robotic sleeve gastrectomy, the sureform 60 stapler was seated in the robot arm and inserted into the port site, and the robot did not recognize the load and the jaws would not open.The load was wrapped in seam guard, which had to be wasted.Sureform 60 stapler lot # l92210222.

• 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: 11862438
• MDR Text Key: 251975177
• Report Number: 11862438
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/13/2021

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 Catalogue Number: 480460
• Device Lot Number: L92210222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Weight: 132