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

Model Number 380614-13

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intra-operative complication can be attributed use of a third-party laparoscopic stapler instrument.The surgeon believes that the cause of the vessel injury was due to the 3rd party laparoscopic stapler instrument not stapling completely.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 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.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 pulmonary segmentectomy procedure, there was an unspecified stapling malfunction with a 3rd party laparoscopic stapler instrument which was inserted via a laparoscopic port.It was alleged that tissue was not stapled.As a result of the stapling issue, there was an injury to the pulmonary vein and uncontrolled bleeding occurred.The procedure was converted to open to control the bleed.The patient received a blood transfusion and had prolonged hospitalization.Per the surgeon, the cause of the intra-operative complication can be attributed to use of the third-party laparoscopic stapler instrument.However, it is unclear to what degree, if any, the da vinci surgical system contributed to the intra-operative complication.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

Event Description

It was reported that during a da vinci-assisted pulmonary segmentectomy procedure, the first assist attempted to use an unspecified 3rd party laparoscopic stapler instrument to perform stapling.As a result of a stapling failure, an injury to the left superior pulmonary vein occurred.Due to uncontrolled bleeding, the surgical field could not be effectively visualized.The procedure was converted to open.The bleeding was controlled, and the patient was stabilized.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: the 3rd party stapler instrument was inserted through an auxiliary port, 12 mm trocar in the seventh intercostal space.The first assist was trying to resect the lung segment with the 3rd party stapler instrument when the stapling failure occurred.It was alleged that tissue was not stapled, and an infiltration of the left superior pulmonary vein was observed.The surgeon believes that the cause of the vessel injury was due to the 3rd party stapler not stapling completely.There was no da vinci system, instrument or accessory malfunction that caused or contributed to the intra-operative complication.There was no unexpected movement of the instrument or system arm that led to the injury, no issues with visualization of the surgical field as well as no anatomical factors that caused the injury.The surgeon stated that pulmonary vein bleeds are difficult to control, and he failed to control the bleed with a 3rd party titanium staple.The bleeding also made it difficult to visualize the bleeding point.The bleeding was eventually controlled by placing sutures in the open procedure.The patient received a blood transfusion and required prolonged hospitalization.Patient demographics were asked but not provided.

• Brand Name: DAVINCI SI
• 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: 14213526
• MDR Text Key: 290113672
• Report Number: 2955842-2022-11254
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380614-13
• Device Catalogue Number: 380614
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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
• Patient Weight: 120 KG
• Patient Ethnicity: Hispanic