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

Model Number 400180-14

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2020

Event Type  malfunction  

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 confirmed the customer reported complaint of ¿crack through clear plastic starting to extend into dark grey plastic¿.The mcs tip cover accessory was found to have tearing at the distal mouth.The tear was axially aligned with the mcs tip cover accessory and measuring 0.202¿ in length.A piece measuring roughly 0.307¿ x 0.054¿ in size was missing from the tear.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.Part #400180-14/lot #m91191111, mcs tip cover accessory, does no show in the logs due to the part being an accessory.Therefore, a accessory log review of the product related to the complaint cannot be performed.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 grey part of the accessory, which could lead to arcing.In addition, a piece measuring roughly.307¿ x.054¿ in size was missing from the tear, and it is unknown if the piece fell into the patient.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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, a crack through clear plastic starting to extend into dark grey plastic was noted 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 accessory was inspected prior to use.The mcs tip cover accessory was appropriately installed without electrolube.No smoke, sparks or arcing was seen during the case.The surgeon believed that the cause of the mcs tip cover accessory tearing was due to normal use.No pictures or videos were available for further review.

• 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: 10187482
• MDR Text Key: 231110750
• Report Number: 2955842-2020-10591
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111048
• UDI-Public: (01)00886874111048(17)211130(10)M91191111
• 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
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: M91191111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2020
• 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