MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; TIP COVER ACCESSORY

Model Number 400180-14

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) tip cover accessory involved with this complaint and completed the device evaluation.Failure analysis investigation replicated/confirmed the customer reported complaint of ¿split extending into the dark gray plastic¿.The mcs tip cover accessory was found to have tearing at the mouth on the distal end.Tears were axially aligned with the mcs tip cover accessory, measured 0.180¿ in length and reached the gray silicone area.There were no signs of thermal damage present at the end of any tears.Tears at the mouth are most commonly caused by repeated thermal and mechanical stress.System log review: the part #400180-14/lot #m91191108 does not show in the logs due to part being an accessory.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.No image or video clip for the reported event was submitted for review.No other complaints related to this event have been reported.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the mcs tip cover accessory had a tear on the gray part of the accessory, which could lead to arcing.Although no arcing was seen and no patient harm, adverse outcome or injury occurred, if this malfunction were to recur it could cause or contribute to an adverse event.In addition, the mcs tip cover accessory fell inside of the patient during the mcs instrument removal from the patient.All fragments were retrieved and no additional surgical intervention was required.However, unintended fragments falling inside the patient may require surgical intervention.At this time, it is unknown what caused the mcs tip cover accessory to fall inside of the patient.

Event Description

It was reported that during a da vinci-assisted surgical procedure, a split was extending into the darker gray plastic on the monopolar curved scissors (mcs) tip cover accessory.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the da vinci coordinator and obtained the following additional information: the mcs instrument and the mcs tip cover accessory were inspected prior to use and no damage was noted.The mcs instrument and the mcs tip cover accessory were in use approximately four hours intermittently, and then a tear on the was noted on the mcs tip cover accessory.While the mcs instrument was being removed from the patient, the mcs tip cover accessory fell inside of the patient having possibly gotten caught on the cannula.The mcs tip cover accessory was retrieved with a laparoscopic instrument.There was no mcs instrument functionality issue noted.It is unknown if the mcs instrument collided with any other instruments, if the surgical staff felt any resistance upon removal of the instrument through the cannula, or if the instrument wrist was straightened upon removal.The surgical staff did not notice any damage to the mcs instrument or cannula after the event occurred.The mcs tip cover accessory was appropriately installed with an installation tool and no electrolube was used.It was also confirmed that the mcs tip cover accessory was not installed beyond the orange surface.No photographic image or video recording of the procedure were available.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1: b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

• Brand Name: DA VINCI
• Type of Device: TIP COVER ACCESSORY
• 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: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10215881
• MDR Text Key: 230622539
• Report Number: 2955842-2020-10617
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111048
• UDI-Public: (01)00886874111048(17)211130(10)M91191108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: M91191108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES