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

Model Number 470179-19

Device Problem Break (1069)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm monopolar curved scissors (mcs) instrument involved with this complaint and completed the device evaluation.The failure analysis investigation replicated/confirmed the customer reported complaint.The mcs instrument was found to have a broken tube extension at the distal end.A broken piece, measuring roughly 0.153¿ x 0.322¿ in size, was not returned.The root cause of the broken tube extension is attributed to mishandling/misuse.An additional observation not reported by site was also identified: the mcs instrument was found to have signs of corrosion on the instrument bearings and exhibited the orange discoloration on the grip input disk bearings.The root cause of the corroded/contaminated instrument bearings is typically attributed to mishandling/misuse, most commonly caused by improper cleaning/reprocessing techniques.A review of the instrument log for the mcs instrument (470179-19/ k13210907 0133) associated with this event has been performed.Per logs, the mcs instrument was last used in a procedure on (b)(6) 2021 via system (b)(4).The alleged instrument had 4 uses remaining after the last procedural use.An event verification confirmed the procedure was performed on the reported event date.A review of the site's complaint history found that there were no other complaints for this product.No image or video of the procedure was provided for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis acknowledged that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling inside the patient, the reported failure mode could likely cause or contribute to an adverse event if a fragment did fall inside the patient.

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, the 8mm monopolar curved scissors (mcs) instrument had a crack in the orange sheath.The procedure was completed with no reported injury.The endowrist monopolar curved scissors is intended to be used with the da vinci system for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Field b3 was updated to provide the correct event date.The event date was 12/16/2021 rather than (b)(6) 2022 which was initially reported.

• 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: 14132086
• MDR Text Key: 298868536
• Report Number: 2955842-2022-11104
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112298
• UDI-Public: (01)00886874112298(11)210902(10)K13210907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2022
• 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: K13210907 0133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female