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

Model Number IS3000 A6.0P9

Device Problem Device Stops Intermittently (1599)

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

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

The camera head has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.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 no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci abdominoperineal resection procedure, the surgical staff noted that they had intermittent interference with their image on both the touchscreen and surgeon side console when using cautery.The customer had taken multiple actions prior to calling intuitive surgical inc.(isi) technical support.Reportedly, the surgeon made the decision to convert the planned surgical procedure to open surgical techniques.No patient harm, adverse outcome or injury was reported.An isi technical field specialist (tfs) visited the site and performed extensive troubleshooting using the monopolar curved scissors (mcs) instrument and instrument cables that were used during the case.The tfs noticed background noise and lines of interference present on the image as reported by the customer.The camera cable was replaced however the image interference did not change.The tfs setup the vision system with the customer's endoscope and instrument and was able to recreate grid-like interference during cautery firing when the instrument cable was in close proximity to camera cable connection on camera head.The tfs installed the customer's backup camera head and was unable to replicate interference issue.On 10/13/2015, intuitive surgical, inc.(isi) contacted the initial reporter and the initial reporter corroborated the tfs finding that the source of the interference was the camera head.

• 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
• MDR Report Key: 5151181
• MDR Text Key: 28706275
• Report Number: 2955842-2015-01285
• 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: health professional
• Reporter Occupation: Other
• Report Date: 09/16/2015

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: IS3000 A6.0P9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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