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

Model Number 470002

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the subcutaneous emphysema is due to misuse and patient anatomical factors.The cannula was lying in the abdominal wall space instead of the abdominal cavity due to adhesions and weak port insertion site.The cause of the pancreatic injury was due to the patient's petite body size and the surgeon's surgical technique of inserting the third-party trocar in a cephalad direction.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Additionally, all reusable instruments used in the case were used in subsequent procedures with the exception of the endoscope and monopolar curved scissors (mcs) and a site review shows no complaint filed against the instruments.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted malignant hysterectomy procedure, the patient had severe subcutaneous emphysema due to the da vinci 8 mm port lying in the abdominal wall instead of the abdominal cavity.As a result of the severe subcutaneous emphysema, the patient had an unplanned admission to the icu.The injury to the pancreas, which required suturing by hepatobiliary and pancreatic surgeons, was due to the insertion of a third-party trocar in a cephalad direction in a patient with a small body habitus.

Event Description

It was reported that during a da vinci-assisted malignant hysterectomy procedure, the pancreas was injured during the insertion of the air-seal port in a patient with a small body habitus.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: the source of bleeding was pancreatic tissue, which was damaged when a third-party airseal port was inserted in the patient.The bleeding was initially stopped by applying compression and hemostatic powder.The surgeon believes that the cause of the pancreatic injury was due to the petite stature of the patient and the cephalad direction of the insertion of the airseal port.According to the surgeon, there was no malfunction of an isi product that caused the pancreatic injury.At the end of the procedure, the pancreatic injury, that was sustained during port placement, began to re-bleed.A hepatobiliary pancreatic surgeon was called into the operation to suture the pancreas to achieve hemostasis.The surgeon believes that the cause of the re-bleeding was due to a pseudoaneurysm formed during tissue damage, suturing, or decrease in the insufflation pressure.No additional tissue resection was required due to the re-bleeding.The amount of blood loss was 500 ml, and the patient did not require a blood transfusion.The patient was also discovered to have subcutaneous emphysema.The surgeon alleged the subcutaneous emphysema was caused by the da vinci 8 mm port, which was used as the insufflation port.The tip of the cannula was lying in the abdominal wall instead of the peritoneal cavity.According to the surgeon, the cause of the subcutaneous emphysema was due to adhesions, weak port insertion site, and the port being made of metal making its surfaces slippery.The patient had an unplanned admission to the icu.

• Brand Name: DA VINCI
• Type of Device: CANNULA
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13285778
• MDR Text Key: 284002589
• Report Number: 2955842-2022-10096
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/20/2021

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: 470002
• Device Catalogue Number: 470002
• Device Lot Number: VE192902
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/18/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female