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

Model Number 470298

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2018

Event Type  malfunction  

Event Description

Da vinci 45 stapler xi.One of the circular pieces from the robotic 45 xi came off the head.At that time, it was noted that 2 other circular pieces were missing.The drape used for that handpiece was checked and nothing was left on it.Appeared that the 2 circular pieces from the head of the stapler were missing prior to this case.Not used on patient.Prior to use.This is the part that did not connect to the patient only the machine.No patient contact.Device is good for 50 firings.Device had 10 fires remaining.

• 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: 7511014
• MDR Text Key: 108175296
• Report Number: 7511014
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2018

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: No Information
• Device Model Number: 470298
• Device Lot Number: S101512290014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR