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

Model Number 380652-37

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the universal surgical manipulator (usm).The system was tested and verified as ready for use.Isi received the part(s) involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed and replicated the reported event.The unit was tested on an in-house system and passed normal mode.The unit failed a pftp as it failed the pitch friction very slow and speed low test.The unit went through more testing on a pftp and passed direction tests, lissajous, cva characterization, sine cycle, carriage friction test, brake release test, brake hold test, advanced brake test, carriage strength test, and carriage switches test.The pitch motor module, pitch harmonic drive, and elbow bearings will be replaced as the fix the reported problem.A log review confirmed the procedure date of (b)(6) 2022 on system sk1135.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: a usm was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 usms.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a conversion/abortion.

Event Description

It was reported that during a da vinci-assisted incisional hernia surgical procedure, a customer was having an ongoing issue with an instrument on universal surgical manipulator 3 (usm3).Technical support was contacted and the technical support engineer (tse) was informed that the field service engineer (fse) was recently onsite however the issue remains.Prior to calling tech support, the customer had switched from usm3 and is using usm4 for a 3 armed procedure.The tse requested an image of usm3 from the customer which was provided after the call ended.The tse noted the flex strips are being shaped opposite of the guidance provided in the da vinci xi user manual.Live logs were reviewed and no associated issues were identified.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(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 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: 15048671
• MDR Text Key: 304533671
• Report Number: 2955842-2022-13036
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-37
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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