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

Model Number 380652-50

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) went onsite and replaced the blue fiber cable, which was physically damaged.The system was tested and verified as ready for use following the cable replacement.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.A review of the system logs was performed.Per the review, the following was confirmed: system serial - (b)(4), event date - (b)(6) 2022, and procedure name - colostomy closure.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: the customer converted the procedure to laparoscopy after the start of the procedure due to a broken fiber cable at the patient side cart (psc).While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.

Event Description

It was reported that during a da vinci-assisted colostomy closure surgical procedure, the blue fiber cable at the patient side cart (psc) was broken off.It was confirmed that they ended up converting to laparoscopic surgery as they did not had a spare fiber cable or a simulator.A technical service engineer (tse) confirmed with the customer that they were able to get all the pieces out of the fiber port.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and patient demographic information was requested, but not provided.

• 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: 14132370
• MDR Text Key: 298865267
• Report Number: 2955842-2022-11113
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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