MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; GENERATOR,E-100

Model Number	374848-09
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The isi fse replaced the e-100 generator to resolve the reported issue.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform a failure analysis.The e-100 generator was analyzed and found to have no failures.The e-100 generator was installed onto the test system, and it worked fine with the vessel seal instrument installed.The vessel seal extend instrument was used with a saline dipped gauze in the jaws and fired the yellow pedal/sync activations for the cut/seal function about 100 times, and the e-100 generator worked fine without any issue.The complaint was not confirmed based on failure analysis.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the e-100 generator failed to fire intermittently.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following information: the customer was unable to provide additional information.

• Brand Name: DA VINCI XI
• Common Device Name: GENERATOR,E-100
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19281326
• Report Number: 2955842-2024-14436
• Device Sequence Number: 15042517
• Product Code: NAY
• UDI-Device Identifier: 00886874116982
• UDI-Public: 00886874116982
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 374848-09
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown