MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number 380990-03

Device Problems Computer Software Problem (1112); Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

The illuminator has been returned to isi for failure analysis evaluation.The unit was installed on an in-house pca system and it powered on with no trouble found.Visual inspection found that the illuminator was in good condition.This complaint is being reported due to a da vinci surgical system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, 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 hysterectomy procedure, the system faulted upon power up and the customer attempted to perform a power cycle of the system.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and found a communication error codes 297 and 48248 pointing to the illuminator.Once the surgeon sat at the surgeon console, the surgeon was unable to take control of the arm one.At that time, the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques.There was no report patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse investigation concluded that the system error code 297 and system error code 48248 experienced by the customer was associated with the system illuminator.To resolve the issue, the fse replaced the illuminator.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7666569
• MDR Text Key: 113397121
• Report Number: 2955842-2018-10343
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

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: Health Professional
• Device Model Number: 380990-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2010
• 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