MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOSCOPIC ELECTROSURGICAL INSTRUMENT; MONOPOLAR CURVED SCISSORS

Model Number 420179-22

Device Problems Smoking (1585); Arcing (2583)

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

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

The monopolar curved scissors instrument has not been returned to intuitive surgical, inc.For failure analysis evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Based on the information provided, this complaint is being reported due to the following conclusion: potential arcing instrument.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the cord and endowrist started smoking.The procedure was completed with no reported patient injury nor harm.Intuitive surgical, inc.(isi) made multiple attempts to contact the reporter to obtain additional information about the complaint; however, attempts were not successful.

• Brand Name: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: pat flanagan ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8484612
• MDR Text Key: 140963858
• Report Number: 2955842-2019-10257
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420179-22
• Device Lot Number: N10181114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2018
• Is the Device Single Use?: No
• 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