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

Model Number 380614-13

Device Problems Loss of Power (1475); Battery Problem (2885)

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

Event Date 09/16/2021

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 was able to reproduce the reported problem.The fse checked the operation status while powering on the patient side cart (psc).The fse noted that the psc would not power on, and the psc battery energy was exhausted.The fse replaced the psc power cable to resolve the reported problem.The system was tested and verified as ready for use.The affected part (psc battery cable - 182440) involved with this complaint is a field scrap item and will not be returning to isi for further investigation.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted to isi for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopic.Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted esophagectomy transthoracic surgical procedure, the intuitive surgical, inc.(isi) clinical sales representative (csr) called in to report that the patient side cart (psc) was running on battery, and it would not charge while docking to the patient.The csr was not present during the surgical procedure.The isi technical support engineer (tse) contacted the site and had the customer verify that there was power in the wall power outlet, both ends of the psc power cord were connected firmly, the circuit breaker was in the on position, and the emergency power off (epo) button was not pressed.The tse had the customer hard power cycle the psc; however, the issue persisted.It was noted that there was no fan noise when the circuit breaker was switched to the # 1 position.The surgeon then elected to convert to laparoscopic surgery.The customer reported that sometimes when the psc lost power and running on battery, the issue could be resolved by wiggling the psc power cable.The tse had the customer switch the power cable between the surgeon side console (ssc) and psc, and it was found that the psc power cable was defective.The customer did not have a spare da vinci system to use at that time.The procedure was converted to laparoscopic surgery with no reported injury.On 21-sep-2021, isi obtained the following additional information from the customer regarding the reported event: the system was reportedly inspected prior to use, and no issues/errors were noted.The reported issue was not identified prior to the procedure starting.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12630854
• MDR Text Key: 282791972
• Report Number: 2955842-2021-11306
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380614-13
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES