MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS3000 A60P9B

Device Problems Calibration Error (1078); Mechanical Problem (1384); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.Has not received the ecm for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined at this time.A follow-up mdr will be submitted if the ecm is returned (post failure analysis evaluation) or if additional information is received.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although, there was no report of patient harm, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci assisted procedure, the endoscopic camera manipulator (ecm) arm faulted with an error.The surgical staff had reset the system but the fault persisted.The customer further stated that the system had powered on and homed with no issues.The endoscopes were calibrated and installed and during docking of the patient side cart (psc), the ecm faulted.Due to the reported error message, the surgeon made to the decision to convert and complete the procedure using traditional laparoscopic techniques.There was no report of patient harm, adverse outcome or injury.An isi technical field specialist (tfs) was dispatched to the facility and swapped out the remote arm controller (rac) and the cables were verified, however, the issue persisted on the ecm arm.The tfs replaced the ecm to resolve the issue.

Manufacturer Narrative

The endoscopic camera manipulator (ecm) arm was returned for failure analysis and the reported failure was confirmed.Engineering was able to replicate the customer reported system error 25588 when the arm was installed on a test system and upon start up.The fault could not be recovered and the arm would not home.The ecm is the camera arm located on the patient side cart, which provides the sterile interface for the 3d endoscope.The system was repaired by replacing the affected ecm.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 5726027
• MDR Text Key: 48419980
• Report Number: 2955842-2016-00433
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1