MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MONOPOLAR CURVED SCISSORS

Model Number 470179-19

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

The monopolar curved scissors (mcs) instrument has not been returned to isi for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the site's system logs for the reported procedure date was conducted by rpms analyst.Investigation revealed the mcs instrument part# and lot# provided were not found in the log files.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.This complaint is being reported due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage with no evidence or claim of user mishandling or misuse.At this time, it is unknown what caused the thermal damage to occur.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.Blank mdr fields: follow-up was attempted, but part of the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is not applicable because the product is not implantable.Information for the blank fields in name and address is not available.Fields pma/510(k) number and adverse event are not applicable.The device manufacture date is unknown at this time.

Event Description

It was reported that during central processing, the monopolar curved scissors (mcs) instrument returned from central reprocessing where a visible char/burn was noticed on the orange section of the instrument.There was no report of patient involvement or reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the sterile processing department noticed the burn on the orange section of the mcs instrument after it was processed.The instrument was not put back into circulation.The customer stated they were unable to pinpoint when the thermal damage occurred as it was not identified during or after a procedure by the surgical team.During the last procedural use of the instrument, the mcs tip cover accessory was installed with the installation tool and it appeared to be properly installed with no bulges or orange surface visible.The surgeon did not experience any issues with the mcs instrument during the surgical procedure.No damage was identified on the mcs tip cover accessory, mcs instrument, or cannula after the procedure occurred.The customer stated there was no injury to the patient.

Manufacturer Narrative

D11 - intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.For clarification, the instrument was found with thermal damage to the distal end of the tube extension.Black char marks were observed on the orange section.Any material missing is likely to be thermally induced rather than mechanically induced.Root cause is attributed to user mishandling/misuse.Failure analysis found the primary failure of thermal damage to the tube extension to be related to the customer reported complaint.The electrical continuity test still passed.The tip cover that would cover the tube extension was not returned with the instrument at the time failure analysis was conducted.Instrument with energy cable was connected on system arm and erbe recognized unit on every attempt.Energy activation test was then conducted with the unit.Grounding pad with wet sponge began to smoke when energy pedal was pressed.Energy activation using various setting was performed with no issues.No unintended arcing occurred during testing.A review of the instrument log for the monopolar curved scissors instrument (pn# 470179-19 lot# n10210125-0449) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system sl0508 for approximately 1 hour and 8 minutes.The alleged event occurred on the 7th use of the instrument with 3 remaining.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 12850438
• MDR Text Key: 281067012
• Report Number: 2955842-2021-11568
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112298
• UDI-Public: (01)00886874112298(10)N10710125
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470179-19
• Device Catalogue Number: 470179
• Device Lot Number: N10210125 0449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.