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

Model Number 380675-02

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the patient¿s post-operative complication is unknown.Isi has attempted to contact the site to gather additional information regarding the patient/incident.However, as of the date of this report, no new information has been obtained.If additional information is received, a follow-up mdr will be submitted.A system or instrument logs review cannot be performed due to the lack of product and procedure information on file at the time.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: after a da vinci-assisted pulmonary lobectomy procedure, the patient was admitted to the icu due to an air leak.According to the surgeon, the air leak allegedly occurred from the bronchus.As a result of the post-operative complication, the patient was taken back to the or for re-closure of the bronchial stump.Although the surgeon indicated that a "covidien tri-stapler" (a 3rd-party manufacturer product) was used during the procedure, the cause of the post-operative air leak is unknown.

Event Description

It was reported that after a da vinci-assisted pulmonary lobectomy procedure, the patient was admitted to the intensive care unit (icu).The patient reportedly suffered from a post-operative air leak.According to the surgeon, the air leak occurred from the bronchus.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: the procedure was done in the presence of a proctor.The stapling was done by an assistant with a "covidien tri-stapler." the patient was taken back to the or for re-closure of the bronchial stump.The patient went to the icu following surgery as a precaution because of significant comorbidity.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM, RECERTIFIED
• 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: 14229127
• MDR Text Key: 294647536
• Report Number: 2955842-2022-11271
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380675-02
• Device Catalogue Number: 380675
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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