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

Model Number IS3000 A60P9B

Device Problem Malposition of Device (2616)

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

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.Technical field specialist conducted additional investigation of the system on site.The error could not be reproduced, but was verified through the logs.The technical field specialist replaced the endoscopic camera manipulator to resolve the system issue.The endoscopic camera manipulator has not yet been received at intuitive surgical for failure analysis investigation.The root cause of the customer reported failure mode has not been determine.A follow-up mdr will be submitted when the part is returned and evaluated and/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 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 nephrectomy surgical procedure, a nonrecoverable fault continually popped up when installing the endoscope.The re-occurrence of the error led the surgeon to convert to a laparoscopic procedure.The reporter contacted intuitive surgical, inc.Technical support when the issue occurred.The patient was under anesthesia and ports had been placed.

Manufacturer Narrative

The endoscopic camera manipulator(ecm) arm was returned to intuitive surgical, inc.For failure analysis investigation.The 23000 system error reported by the customer was reproduced and multiple potentiometer errors were found in the system logs.The 23000 system error code appears when the da vinci safety system determines the rate of change in the angular position of one or more robotic joints on the specified manipulator (ecm), as measured by that joint's primary control sensor (encoder) and the secondary sensor (potentiometer), are out of specified tolerance for agreement.The axis 3 digital potentiometer was replaced to correct the 23000 error.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 cause or contribute to an adverse event.

• 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: 5347706
• MDR Text Key: 35619979
• Report Number: 2955842-2016-00006
• 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: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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