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

Model Number	430035-11
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.An rma was issued to evaluate the single-port monopolar curved scissors tip.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint did show patient identifier (b)(6) as a related complaint (in the same procedure, another instrument had a fragment fall into the patient).
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon had been operating for more than 2 hours when the single-port monopolar curved scissors (mcs) tip fell off of the single-port mcs instrument.A new tip was installed, and the procedure continued using the mcs instrument.The fragment was retrieved during the same procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: only 1 instrument had a failure.These items were inspected before use and no irregularities were noted.The surgical task was manipulating tissue.The surgeon was unaware of the malfunction until the piece that fell of was seen in the field.Approximately 2 hours as indicated in the initial paperwork that was filled out for the return.No function or collision issues were noted.Instrument performed normally up until the piece was noticed in the field.Wrist straight, normal removal, no cannula damage, no other damage noted.Fragments retrieved with another instrument.Fragments retrieved confirmed visually.No additional procedures were required and there was no post operative test performed.The procedure was completed robotically.There was no patient injury, and the patient did not return due to issue.No media available for review.
Additional Manufacturer Narrative
The single-port (sp) monopolar curved scissors (mcs) tip has been evaluated by the failure analysis (fa) team.Fa was not able to reproduce or confirm the reported complaint.The sp mcs tip was installed on an in-house instrument and did not fall off the in-house instrument.Additional observations not reported by site that are not related to the customer reported complaint: the sp mcs tip failed the fit test with tip recognition failure.The sp mcs tip was found to have a broken lance.A piece approximately 0.086" x 0.06" in size was missing and not returned with the sp mcs tip.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: MONOPOLAR CURVED SCISSORS (MCS) TIP
• 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: 17999885
• Report Number: 2955842-2023-19559
• Device Sequence Number: 7548702
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(10)K10221006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430035-11
• Device Catalogue Number: 430035
• Device Lot Number: K10221006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: Unknown