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

Model Number	380675-04
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
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 complaint.The fse replaced the personality module surgeon console (pmsc).The system was tested and verified as ready for use.Isi has requested the pmsc involved with this complaint be returned but it has not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.No image or video was available for review.Patient identifier (b)(6) is created to capture the blank eye issue on the surgeon side console (ssc) which is related to patient identifier (b)(6).A review of the site's system logs for the reported procedure date was conducted by technical support when the customer called for troubleshooting assistance.Investigation revealed error 1000 related to the psc power switch related to the reported complaint.An event verification confirmed the procedure was performed on the reported event date (b)(6) 2022 on system (b)(4).This complaint is reportable malfunction event due to the following: the customer converted after the start of the procedure due to non-recoverable errors.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 conversion.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, there was no light on the power switch on the patient side cart (psc).An intuitive surgical, inc.(isi) technical support engineer (tse) checked the logs and found error 1000 related to the psc power switch.An isi tse stated the customer that the power switch needed to be replaced.The procedure was converted to laparoscopy with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the procedure was converted to laparoscopy due to system malfunction.The system functionality was checked upon powering on the system.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the patient back plane (pbp) involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation could not replicate/confirm the customer reported complaint.In-house fa installed pbp into printed circuit assembly (pca) on the si system and the powered up in normal mode with no error.It passed communication ports, fibers led's lit, working switches, ten power cycles no issue.There was no trouble found.The pbp will be scrapped due to contamination.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Additional information can be found in the following fields: d9, g3, g6, h2 and h3 evaluation information can be found in the following fields: h10 an intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse reproduced the reported issue and replaced the tiller on/off switch but the issue still persisted.The fse replaced the patient back plane (pbp) to resolve the issue.The system was tested and verified as ready for use.Isi has requested the pbp involved with this complaint be returned but it has not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.

• Brand Name: DAVINCI SI
• Common Device Name: 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: 15474657
• Report Number: 2955842-2022-14127
• Device Sequence Number: 11471322
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2022

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: 380675-04
• Device Catalogue Number: 380675
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 11/22/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/23/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian