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

Model Number IS3000 A70P6B

Device Problem Device Issue (2379)

Patient Problems Death (1802); Perforation (2001); Injury (2348)

Event Date 05/25/2017

Event Type  Death  

Manufacturer Narrative

Based on the information provided, isi has not determined the root causes for the alleged loss of insufflation or the intra-operative complication experienced by the patient.There is no allegation that a malfunction of a specific da vinci system, instrument, or accessory occurred.Isi has attempted to contact the surgeon to obtain additional information regarding the reported event.However, as of the date of this report, no further clinical information has been provided.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) 2017.No related system errors were found to have occurred.The system logs also reveal that the harmonic ace curved shears instrument and double fenestrated grasper instrument involved with the reported event have been used in subsequent surgical procedures.No issues involving the instruments have been reported to isi.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the patient allegedly sustained a puncture wound to the right ventricle after insufflation was lost.A cardio surgeon was called and the case was converted to open surgery.The patient reportedly expired due to a pe and mucus plug on post-operative day 20.However, at this time, the root cause of the intra-operative complication is unknown.

Event Description

It was reported that during a da vinci-assisted nissen fundoplication procedure, the insufflation was lost after the surgeon swapped from arm 1 to arm 3.At the time the event occurred, a harmonic ace curved shears instrument was installed on arm 1 and a double fenestrated grasper instrument was installed on arm 3.As a result of the loss of insufflation, the patient's diaphragm slid down and the harmonic ace curved shears instrument allegedly punctured a hole in the patient's right ventricle.Once the surgeon identified the operative complication, a cardio surgeon was called for immediate open heart surgery.On 06/21/2017, intuitive surgical, inc.(isi) contacted the surgeon and obtained the following information regarding the reported event: the site has not determined the cause of the loss of insufflation during the surgical procedure.No issues were identified with the insufflation tubing, assist port, cannulas, or cannula seals.The surgeon believes the puncture wound to the patient's right ventricle occurred as a result of the loss of insufflation and movement of diaphragm.No instruments were moved after insufflation was lost.At the time the event occurred, the surgeon was reducing the stomach from the mediastinum.The surgeon indicated that the patient expired on post-operative day 20 due to a pulmonary embolism (pe) and mucus plug.No further clinical information was provided.

• 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 ; 4085232420
• MDR Report Key: 6662320
• MDR Text Key: 78230756
• Report Number: 2955842-2017-00392
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000 A70P6B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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): Death; Life Threatening; Required Intervention