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

Catalog Number 470347

Device Problems Use of Device Problem (1670); Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2021

Event Type  malfunction  

Event Description

When instrument was installed, lights on da vinci arm were flashing yellow.An error message was shown on the screen stating "instrument was not recognized".Instrument was removed and replaced into da vinci arm, but the same message occurred.Writer grabbed a new instrument and opened to sterile field.When installed into arm, instrument was recognized and was able to be used.Unrecognized instrument was not inserted into patient port.Instrument marked as "broken" and taken off of field.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 12370164
• MDR Text Key: 268249031
• Report Number: 12370164
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 470347
• 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: 08/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 80