MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-48

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported injury cannot be determined or is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.If additional information is received, a follow-up mdr will be submitted.A site complaint history review was performed and found that there were no other complaints related to this product.A system log review was performed and revealed there were no related system errors to have occurred during the surgical procedure.Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: maryland bipolar forceps instrument and site reviews have shown that no complaints were filed against the instrument.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 total hysterectomy with a sacrocolpopexy surgical procedure, the common iliac vein tore.As a result, the procedure was converted to open surgery and a vascular surgeon repaired the iliac vein.The amount of bleeding was about 500 ml.The cause of the reported vessel injury is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted total hysterectomy with a sacrocolpopexy surgical procedure, approximately 40 minutes into the procedure, the common iliac vein tore.It is unclear what surgical task was being performed when the intra-operative complication occurred.As a result of the vessel injury, the procedure was converted to open surgery.After the conversion to laparotomy, a vascular surgeon took over to repair the injured vessel.The amount of bleeding was about 500 ml, and the patient was reported to be recovering well.As a result of the injury, the planned surgical procedure was not completed.Intuitive surgical, inc.(isi) contacted the or lead, and the following information was obtained: the or lead confirmed there was no malfunction of an isi instrument or system, and it was unknown if a da vinci instrument had contact with the vessel that was injured.No additional information regarding the reported incident was available.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 13101568
• MDR Text Key: 287272540
• Report Number: 2955842-2021-11822
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-48
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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