MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SURGICAL XI SYSTEM ROBOT ARM USM2; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 380647-25

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Event Description

During the patient's surgery, one of the arms malfunctioned alarmed a nonrecoverable fault.Multiple attempts were made to fix the problem without success.A different arm was used to continue the case.No patient harm.Intuitive rep present during case.Model xi.This is malfunctioned arm usm2 ¿ arm part number 380647-25.

• Brand Name: DA VINCI SURGICAL XI SYSTEM ROBOT ARM USM2
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 10282190
• MDR Text Key: 199070919
• Report Number: 10282190
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380647-25
• Device Catalogue Number: 380647-25
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA