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

Model Number IS3000 A6.0P8

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Bowel Perforation (2668)

Event Date 04/30/2014

Event Type  Injury  

Event Description

It was reported that during a da vinci right hemicolectomy procedure, after the physician's assistant at the patient side cart installed an endowrist instrument, the surgeon was unaware that he had control of the installed instrument as he was unable to view the instrument through the high resolution stereo viewer on the surgeon side cart because the endoscope was not completely inserted into the patient.After the surgeon located the instrument, he noted that he had created a small incision.The surgeon repaired the defect with sutures.On (b)(4) 2014, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) who reported this complaint.According to the csr, she was present during set-up of the system; however, she did not witness the injury to the patient as she left the or.The csr indicated that upon her return to the operating room, she observed that the surgeon was trying to locate the tips of the installed instruments and after the surgeon located the tips of the instruments she overheard the surgeon state that he had created a hole in the patient's duodenum.The surgeon used the da vinci surgical system to repair the defect using sutures.The csr indicated that she does not know which instrument introduced the damage to the patient's duodenum.The surgeon completed the surgical procedure using the da vinci surgical system and there were no other issues.According to the csr she spoke to the surgical technician that was present during the surgical procedure.The surgical technician indicated that the endoscope was not all the way inserted into the patient, thus the surgeon believed that he did not have control of the instruments since he could not locate the tips of the instruments.This resulted in a puncture to the patient's anatomy.The csr indicated that there was no report that the patient suffered any post-surgical complications as a result of the reported event.

Manufacturer Narrative

Based on the information provided, it has been determined that the da vinci surgical system, instruments and/or accessories did not cause or contribute to the injury sustained by the patient, but occurred as a result of the surgeon's attempt to locate the tips of the endowrist instruments while he was not aware that he had control of the instruments.The da vinci si user manual specifically states: warning / caution: for patient safety, the surgeon must not match grips for instruments whose tips are not visible in the stereo viewer.Failure to observe this warning can cause serious harm to the patient.Instrument tips should be kept in the view of the surgeon at all times.Review of the site's system logs for the reported procedure date found that no system errors were generated that would have caused or contributed to the injury sustained by the patient.This complaint is being reported due to the following conclusion: the patient's duodenum was perforated during a da vinci right hemicolectomy procedure.However, the patient's injury can be attributed to use error.There was no report by the site that a malfunction of the da vinci surgical system, instruments and/or accessories occurred during the surgical procedure.

• 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: 3841015
• MDR Text Key: 20860040
• Report Number: 2955842-2014-03343
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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): Required Intervention