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

Model Number N/A

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 07/18/2021

Event Type  Injury  

Manufacturer Narrative

Although the author correspondence indicated the complications in question were not due a system malfunction and are expected complications after partial nephrectomy regardless of surgical modality, the root cause of the reported post-operative complications cannot be determined or is unknown.There is no allegation of a da vinci product malfunction, so no product is expected for return and failure analysis.If additional information is received, a follow-up mdr will be submitted.System and instrument log reviews could not be performed due to a lack of system, procedure, and instrument detail.A site history complaint review could not be confirmed due to a lack of product information and procedure dates.No image or procedure videos were provided for review related to a specific event.However, procedure images were provided within the article (in figures 1, 2, and 3) show what appears to be robotic ports and unspecified third party trocars for multiport procedures.An isi clinical development engineer (cde) conducted a clinical image review and the following was noted: the si system is indicated for urological procedures like partial nephrectomy.Some of the robotic ports appear to be placed more than 8-10cm from each other, although this cannot be confirmed from these images alone.Internal instrument collisions may be more frequent when robotic ports are placed further than 8-10cm from each other.Instrument collisions cannot be confirmed without a procedure video.This port placement may not strictly adhere to our port placement recommendations, but misuse or mishandling cannot be confirmed.No additional insights can be provided from the images alone.This complaint is being reported due to the following conclusion: within the journal article titled, ¿use of bariatric ports in 4-arm robotic partial nephrectomy: a comparative study with the standard 3-arm technique," it is noted that two patients required post-operative selective arterial embolization for postoperative bleeding/ hematoma.Even though the author correspondence indicated the post-operative complications were not due a system malfunction, the causes of the complications are unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Follow-up was attempted, but the patient information b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.If the initial reporter submitted a report to the fda.Insufficient product information was provided in order to obtain the date of manufacture.

Event Description

Intuitive surgical, inc.(isi) became aware of a cureus journal article titled, ¿use of bariatric ports in 4-arm robotic partial nephrectomy: a comparative study with the standard 3-arm technique¿ (el-asmar, j.M., sebaaly, r., et al., 2021).Within the journal article, post-operative complications involving a da vinci surgical procedure were noted: "two patients required postoperative selective arterial embolization for postoperative bleeding/ hematoma." isi contacted the author correspondence who confirmed that these cases were performed in their center.The author correspondence indicated that none of the complications in question were due to a system malfunction and "these occurrences are expected complications after partial nephrectomy and are inherent to this type of surgery whatever the approach open, laparoscopic or robotic.".

• Brand Name: DA VINCI
• Type of Device: DA VINCI SURGICAL SYSTEM
• 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: 13029191
• MDR Text Key: 287209901
• Report Number: 2955842-2021-11768
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/22/2021

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/17/2021
• 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 Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES