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 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Part #400180-14/lot #m91194444, mcs tip cover accessory, does not show in the logs due to the part being an accessory.Therefore, an 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 were 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.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 tear into the darker grey plastic of the monopolar curved scissors (mcs) tip cover accessory was noted.No arcing was observed.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 tip cover accessory was applied appropriately with the installation tool.No smoke or sparks were seen.The surgeon believed that the cause of the tearing was due to normal use.

Manufacturer Narrative

Additional information can be found in the following sections: d4, g7, h2, h10.The udi for the product was obtained.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 10172249
• MDR Text Key: 205539611
• Report Number: 2955842-2020-10578
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: M91194444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES