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

Model Number 380990-08

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned to isi for failure analysis evaluation. Failure analysis replicated/confirmed the illuminator issue. The unit was installed on an in-house pca system and it failed during power up. System error code # 48238 was generated. Visual inspection found that the unit's fan was very dusty. The unit will be repaired. 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, system error code #297 was generated and the illuminator would not turn off. The customer contacted intuitive surgical, inc. (isi) for technical support assistance. The isi technical support engineer (tse) instructed the customer to reseat the lamp module, however, after restarting the system, system error code #297 recurred. The tse then instructed the customer to power down the system, remove the illuminator control cable and restart the system. After restarting the system, error code #48238 was generated. The customer was able to recover the fault, however, the customer made the decision to use a third party illuminator to complete the planned surgical procedure. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the site. The fse was able to reproduce the customer reported complaint the fse investigation concluded that the system error code #297 and system error code #48238 were associated with the illuminator. To resolve the issue, the fse replaced the illuminator. The illuminator provides the light which is transported to the system endoscope and projected onto 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: 7653209
• MDR Text Key: 112871565
• Report Number: 2955842-2018-10340
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 380990-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse