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

Model Number 400180-14

Device Problem Crack (1135)

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

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The monopolar curved scissors (mcs) tip cover accessory involved in this complaint has not been returned to intuitive surgical, inc.(isi) for evaluation.If the product is returned, or if additional information is received, a follow-up mdr will be submitted.The mcs instrument that was used during the procedure has been returned and failure analysis was completed.The instrument was found to have a deep scratch mark, approximately 0.05¿ to the surface of the brown section of the tube extension, with material removed and missing.Any potential fragments from the brown section of the tube extension would be retained by the mcs tip cover accessory.This failure is most commonly caused by mishandling/misuse, such as excessive contact with abrasive, or hard surfaces during transport or reprocessing, or during mcs tip cover accessory installation/removal.The tip cover accessory, when used as intended, provides insulation over a section of the endowrist mcs instrument so that radio frequency (rf) energy is only available at the instrument scissor tips.A review of the site's complaint history was performed and no additional records were found for the mcs tip cover accessory.This complaint is being reported because the orange area of the mcs instrument was visible through the gray area of the mcs tip cover accessory.It is unknown if the mcs tip cover accessory had physical damage on the gray area.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer saw the orange warnings of the monopolar curved scissors (mcs) instrument through the gray section of the mcs tip cover accessory.There was no reported physical damage to the mcs tip cover accessory.The procedure was completed with no reported injury.

• Brand Name: NONE
• 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: 10745299
• MDR Text Key: 213425464
• Report Number: 2955842-2020-11134
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)N/A
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES