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

Model Number IS3000 A6.0P8

Device Problems Difficult To Position (1467); Device Remains Activated (1525); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 12/27/2013

Event Type  Other  

Event Description

It was reported that during a da vinci myomectomy procedure, the surgeon began to have trouble controlling the patient side manipulators (psm) with the master tool manipulators (mtm).The psm is an instrument arm located on the patient side cart (psc) that provides sterile interface for the endowrist instrument.The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console.One mtm is assigned to the surgeon's left hand (mtml) and one to his right (mtmr).Due to the reported issue, the surgeon made the decision to convert the da vinci myomectomy procedure to open surgical techniques.On (b)(4) 2014, an intuitive surgical, inc.(isi) field service engineer (fse) performed a field evaluation at the site.The fse found a piece of metal jammed in the endoscopic camera manipulator (ecm) foot pedal that was not allowing it to fully disengage.According to the da vinci si user manual, pressing the camera pedal takes all instruments out of following.When you release the camera pedal, the masters resume control of the instruments.After the fse removed the metal object, proper ecm foot pedal operation and control of the psm's were restored.The fse tested the da vinci surgical system to manufacturer specifications.On (b)(4) 2014, isi contacted the fse.The fse stated that within 5 minutes of evaluating the surgeon side console (ssc), he noticed that the ecm pedal was pressed down and stuck.Immediately after noticing that the pedal was stuck, he found a 3 mm x 2 mm unidentified metal object shaped like a 'u' jammed towards the front of the ecm pedal between the rubber portion of the pedal and plastic portion of the ssc.He was able to remove the metal object with tweezers.He was unable to identify what the metal object was or where it came from.He did not see any broken fragments on the ssc.On (b)(4) 2014, isi contacted the robotics coordinator from the site.The robotics coordinator indicated that the surgeon began to experience issues with controlling the psm's mid-procedure.Due to the reported issue with controlling the psm's, the surgeon made the decision to convert to open surgical techniques.According to the robotics coordinator, the open surgery was completed successfully and there were no reported complications.The robotics coordinator was unable to identify the metal object that was found by the fse or where it came from.

Manufacturer Narrative

On (b)(4) 2014, the fse repaired the da vinci surgical system by removing an unidentified metal object that was found to be jammed under the ecm foot pedal.The unidentified metal object is not available for return to isi for evaluation.Isi has reviewed the system logs for the site with a procedure date of (b)(6) 2013.No system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: the surgeon made the decision to convert the da vinci myomectomy procedure to open surgical techniques after encountering issues with controlling the psm's.

• 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 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3591793
• MDR Text Key: 4140773
• Report Number: 2955842-2014-00465
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IS3000 A6.0P8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/27/2013
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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
• Patient Outcome(s): Other