MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI; DA VINCI XI SURGICAL SYSTEM

Model Number	IS4001-01
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Death (1802); Bowel Perforation (2668)
Date of Event	04/25/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on the information provided, isi has not determined the root cause for the reported operative complication experienced by the patient and his subsequent demise.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.If additional information is received a follow-up mdr will be submitted to the fda.Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2018.No related system errors were found to have occurred during the surgical procedure.Based on the information provided at this time, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient underwent another non-robotic surgical procedure to repair a bowel perforation that was discovered post-operatively.The patient reportedly expired.However, at this time, the root causes of the patient¿s operative complication and subsequent death are unclear.
Event or Problem Description
It was reported that after undergoing a da vinci-assisted prostatectomy procedure, the patient¿s bowel was found to be perforated.The patient underwent a non-robotic surgical procedure to repair the bowel perforation.The patient was in recovery and scheduled to be released on (b)(6) 2018.While walking around, the patient reportedly collapsed.The hospital staff was unable to revive the patient.According to the patient¿s wife, she thinks he may have had cardiac arrest.On 24-may-2018, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) who was present during the da vinci-assisted prostatectomy procedure.According to the csr, there were no reports of any intra-operative complications or a malfunction of the da vinci surgical system.The surgical procedure was completed robotically.While in the hospital, the patient became symptomatic post-operatively and a bowel perforation was discovered.The bowel perforation was repaired without the use of robotic surgery.The csr indicated that he was informed by the hospital that the patient¿s death was due to ¿natural causes.¿ the patient¿s death was reportedly related to prior unspecified cardiac issues and a pulmonary embolism.The csr also indicated that he spoke to the surgeon who performed repair of the bowel perforation.According to the csr, the surgeon mentioned that he believes the bowel perforation may have occurred during the ¿guided tool change¿ feature of the da vinci surgical system.Per the da vinci xi surgical system user manual, the following is stated in reference to the guided tool change feature: ¿to provide an efficient and safe method for instrument exchange or reinsertion, the system can assist the patient cart operator by guiding an instrument into the patient.Guided tool change helps guide the instrument tip to a location just short of the last position of the previously installed instrument tip.¿ however, the csr stated that the surgeon did not allege that a malfunction of the da vinci system, an instrument, or accessory occurred.

• Brand Name: DAVINCI
• Common Device Name: DA VINCI XI SURGICAL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7574643
• Report Number: 2955842-2018-10260
• Device Sequence Number: 198277
• Product Code: NAY
• Combination Product (Y/N): N
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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
• Operator of Device: Health Professional
• Device Model Number: IS4001-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Death; Required Intervention