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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DA VINCI CANNULA Back to Search Results
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.
 
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Brand NameDA VINCI
Type of DeviceCANNULA
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 Key13285778
MDR Text Key284002589
Report Number2955842-2022-10096
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131861
Number of Events Reported1
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
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number470002
Device Catalogue Number470002
Device Lot NumberVE192902
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2021
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 NumberN/A

Patient Treatment Data
Date Received: 01/18/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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