MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM; STAPLE, IMPLANTABLE

Model Number 480445

Device Problems Failure to Calibrate (2440); Connection Problem (2900)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

When attempting to load stapler into robot, arm would not engage/calibrate into robot arm.

• Brand Name: SUREFORM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 15833726
• MDR Text Key: 304010501
• Report Number: 15833726
• Device Sequence Number: 1
• Product Code: GDW
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480445
• Device Catalogue Number: 480445
• Device Lot Number: T10220908
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Female