MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-33

Device Problems Loss of Power (1475); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/15/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the surgeon converted the procedure to open surgery due to power shortage and not due to any system, instrument, or accessory issue.An intuitive surgical, inc.(isi) field service engineer (fse) spoke to isi clinical sales representative (csr) about the issue.The csr and the customer understood that the system should not be plugged into a power strip, but rather it is recommended to have each component plugged into a separate wall outlet.The customer understood moving forward that plugging into a wall outlet and restarting system would have been the solution to this issue.No site visit was conducted.The system was working properly, and no additional action was required.

Event Description

After a da vinci-assisted pulmonary lobectomy surgical procedure, an intuitive surgical, inc.(isi) clinical sales representative (csr) reported that the system power shutdown in the middle of the case.The customer was conferenced in and stated that they surge protector tripped and the system shutdown.The customer stated the surgeon opted to covert to open prior to calling in.The isi technical service engineer (tse) reviewed that each unit plus the electrosurgical generator unit (esu) should all have their own dedicated outlets to avoid such issues.The customer acknowledged.The csr acknowledged and stated that they would check on next visit.The procedure was converted to open surgery.Isi followed up with the csr and obtained the following additional information: the procedure was not converted due to an intra-operative complication.The patient tolerated the change well.They converted due to power shortage.The system was inspected prior to use and no issues were noted.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE 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: 17097931
• MDR Text Key: 316935840
• Report Number: 2955842-2023-16127
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/15/2023

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: 381121-33
• Device Catalogue Number: N/A
• Device Lot Number: N /A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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