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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Heart Failure (2206); Injury (2348); Blood Loss (2597)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

4315.Based on the current information provided, the root cause of the patient¿s alleged operative complication is unknown.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the surgeon's procedure history and the site's system logs with a procedure date of (b)(6) 2019.According to the surgeon's procedure history, the surgeon had performed 2 da vinci-assisted ventral hernia procedures at the site on (b)(6) 2019.Per the system logs, no related system errors were found to have occurred during either surgical procedure.At this time, it is unclear which of the two surgical procedures involved the patient associated with the reported event.This complaint is being reported due to the following: after undergoing a da vinci-assisted surgical procedure, the patient¿s husband claimed that the patient was admitted to an icu, received a blood transfusion, and also suffered a heart attack due to blood loss.The patient¿s husband indicated that the hospital informed him that his wife¿s bowel was injured but the complication was part of normal surgical complications.At this time, the root cause of the patient¿s operative complications are unknown.

Event Description

It was initially reported by the patient's husband that after undergoing an unspecified da vinci-assisted surgical procedure, he was informed by the hospital that his wife¿s bowel had been ¿nicked¿ or ¿cut.¿ per the patient¿s husband, he also claimed that the hospital indicated that the injury was part of normal surgical complications.The patient¿s husband reportedly did not understand why the patient was sent home after the operation for two hours, only to return to the emergency room (er).According to the patient¿s husband, as a result of the bowel injury, his wife stayed in the icu for 10 days and received a blood transfusion.In addition, he alleged that the patient experienced a heart attack because of blood loss.On 11/04/2019, intuitive surgical, inc.(isi) contacted the patient¿s husband and obtained the following additional information regarding the reported event: he did not know if the patient had undergone any previous surgical procedures prior to undergoing a da vinci-assisted ventral hernia repair procedure.According the patient¿s husband, the patient was to undergo a robotic hernia pair procedure to fix one defect.However, 4 separate defects were identified and repaired during the da vinci-assisted surgical procedure.The patient¿s husband did not know how the patient developed the hernia.The patient¿s husband provided the following information regarding his wife¿s care: after undergoing the da vinci-assisted ventral hernia repair procedure, the patient returned home on the same day as anticipated.The patient was home for about an hour but did not look good according to the patient¿s husband.The patient reportedly stated that she felt as if something was ¿leaking¿ inside.She returned to the hospital via an ambulance.The er then called the patient¿s husband who is bedridden at home and informed him that his wife was going to be discharged to home.The patient¿s husband stated that he questioned the er¿s decision as he has a background as a military medic.The hospital then reportedly decided to re-evaluate the patient.The er then called the patient¿s husband back to inform him that his wife was anemic and was going to be admitted to the icu as a precaution.The next day, patient¿s husband received a call from the icu nurse caring for his wife.She informed him that his wife was very sick and that she was transfused 6 units of blood.According to patient¿s husband, he did not receive any information or update from the operating physician.He reportedly only spoke with the icu nurse.On day #2, the patient was still in the icu.The icu nurse informed the patient¿s husband that his wife was now septic and delirious.The patient¿s husband stated that this went on for another 4 to 5 days.His wife did not undergo a second operation.A picc line was placed into his wife¿s neck for iv antibiotics.The patient¿s husband stated that two days prior to discharge, his wife suffered a myocardial infarction.The patient¿s husband was reportedly informed by a home health nurse, who was reading the patient¿s medical records that there was a ¿nick in the colon¿ during the procedure.The patient¿s husband indicated that he had contacted the hospital, memorial hospital in gulf port, ms, to find out what happed to his wife.The patient¿s husband claimed that an individual at the hospital stated ¿we didn¿t do, the machine did it.¿ it was not clear as to when that statement was made to patient¿s husband.The patient¿s husband additionally said that an individual from hospital relations stated that his wife¿s case was due to ¿normal complications.¿ additionally, the patient¿s husband stated that he received a call from the hospital¿s risk management department and that they would launch an investigation.

• Brand Name: DA VINCI
• Type of Device: DA VINCI SURGICAL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9395835
• MDR Text Key: 168773519
• Report Number: 2955842-2019-10929
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention