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

Model Number 470049

Device Problems Device Alarm System (1012); Device Reprocessing Problem (1091); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

While loading the caider into the robotic arm, a fault came up stating that the instrument was not useable. The surgeon was the one that loaded it, removed it, and still got the error. We then placed a different instrument into the arm and it worked fine. The instrument did not show a red dot indicating that it was expired. I want to assure that this is not a patient safety concern at this time. The davinci robot does a safety check on every instrument that is loaded into one of the arms. If anything does not test correctly, you cannot use the instrument on the patient; it won't let it enter the patient's body. Here's the info on the instrument in question: cadiere forceps intuitive #470049, lot# n10181003 0057 ver -06. This instrument needs to be cleaned and retested to see if it will be recognized by the davinci xi robot. I have isolated the instrument in question and will be testing it in a non-patient related method. All of the xi instruments on occasion have a potential to have a haze left on them after decontamination. There is an intraop troubleshooting technique of wiping the contacts with a moist sponge that may have helped but was not utilized in this case. I have followed up by giving the staff involved this troubleshooting tip and have requested for additional training in spd for cleaning the xi instruments. The in service is scheduled in spd to refresh on the cleaning techniques and lubrication of the xi instruments.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 8296706
• MDR Text Key: 134748108
• Report Number: 8296706
• 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,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 470049
• Device Lot Number: N10181003 0057 VER -06
• 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: 01/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage