MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number 400180

Device Problem Material Integrity Problem (2978)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted prostatectomy - radical w/ lymphadenectomy surgical procedure, the customer called an intuitive surgical inc.(isi) technical support engineer (tse) to report that they noticed there was a rip in the monopolar curved scissors (mcs) cover.The customer explained they removed the mcs and replaced the torn cover and proceeded with the procedure.Customer explained that the energy was still controlled and there was no patient injury.The customer questioned how the cover could have been torn.Tse recommended the customer rma the ripped mcs cover for failure analysis.The procedure was completed as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the customer reported that the grounding was located on the right upper thigh.The grounding pad did not appear to have any issues or defects.There was no arcing from the monopolar curved scissors (mcs) instrument.It just stopped working.The mcs tip accessory appeared to be installed correctly.The orange surface of the tip cover was not visible.The installation tool was used.There was no lubricant used.There was a small tear to the tip cover.It was intact with no missing pieces.

Manufacturer Narrative

The product has not been returned to intuitive surgical, inc.(isi) for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.As of 1-april-2022, a review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No image or procedure video was provided for review.A review of the system logs was performed.Per the review, the following was confirmed: system serial - (b)(4), event date - (b)(6) 2022, and procedure name - prostatectomy - radical w/ lymphadenectomy.This complaint is considered a reportable event due to the following conclusion: the mcs tip cover accessory was damaged due to it had tears or rips on the gray silicone area.In the event the tip cover is compromised, it is possible for energy to discharge in an area other than the instrument tip.Failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14252267
• MDR Text Key: 291317364
• Report Number: 2955842-2022-11334
• Device Sequence Number: 1
• Product Code: NAY
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male