MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; MONOPOLAR CURVED SCISSORS (MCS) TIP

Model Number	430035-11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the sp monopolar curved scissors (mcs) tip accessory for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer.The image provided appears to show an sp mcs instrument with the sp mcs tip accessory¿s retaining cover dislodged from the instrument.There does not appear to be any missing pieces from what was shown, but the accessory would need to be returned for a full inspection to be sure, as only one of the retaining cover¿s lances is visible in the image.The image appears to show a potentially damaged retaining cover.The white lines on the exterior of the retaining cover where the retaining lance sits, is typically caused by the internal retaining feature being forced outwards.This damage can indicate mis-installation of the accessory which can include over-twisting the retaining cover onto the instrument tube adapter, twisting the retaining cover before the accessory is properly seated on the instrument, or attempting to twist on the retaining cover with the accessory misaligned with respect to the instrument tube adapter.
Event or Problem Description
It was reported that during a da vinci-assisted malignant nipple-sparing mastectomy with implant reconstruction surgical procedure, there were two instances of the sp monopolar curved scissors (mcs) tip disengaging after a collision with the fenestration of the fenestrated bipolar forceps instrument.The surgeon recognized the tip disengaged and the instrument was removed.A new tip was then installed.The tip did not fall into the patient.The case proceeded as normal with just approximately 2 minutes of short delay to install a new tip on the instrument for each instance.The procedure was completed robotically with no patient harm.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 01-may-2024: there was no arcing noted.Customer will not be returning the sp mcs tip.Patient demographics were not provided.

• Brand Name: NONE
• Common Device Name: MONOPOLAR CURVED SCISSORS (MCS) TIP
• 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: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19235987
• Report Number: 2955842-2024-14175
• Device Sequence Number: 8021667
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(10)K10240208
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 430035-11
• Device Catalogue Number: 430035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Prefer Not To Disclose