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 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

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.The mcs tip cover accessory was found to have tearing at the mouth at the distal end.The tear extended into the gray part as well as the clear distal end.The tear was axially aligned with the mcs tip cover accessory and measured approximately 0.227 in length.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 stresses.No log review was performed as instrument log review does not provide any information regarding mcs tip cover accessory.No image or video clip for the reported event was submitted for review.A complaint history review for the site was performed, an there were no additional complaints related to the product identified.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.Although no arcing was seen and there was 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, the monopolar curved scissor (mcs) tip cover accessory was noted to have a tear.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was noted that the issue was identified during procedure, which was completed using a backup mcs tip cover accessory with no adverse effect or injury to the patient.The tear was noted to be on the distal clear silicone tip.There was no instrument collision when the issue occurred.No fragment fell into the patient's anatomy.The issue caused a procedure delay of 10 minutes.

Manufacturer Narrative

The event date has been corrected from (b)(6) 2020 to (b)(6) 2020.

• Brand Name: DA VINCI
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10396642
• MDR Text Key: 243723247
• Report Number: 2955842-2020-10739
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111048
• UDI-Public: (01)00886874111048(17)211231(10)M91191205
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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: M91191205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES