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	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has not received the product involved with the alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the sheath was observed to allegedly separate and come off the single port (sp) monopolar curved scissors (mcs) instrument.The procedure was completed using the backup with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the 8mmmcs tip cover accessory associated with the customer-reported complaint.The accessory was analyzed and was found to have a dislodged retaining tip cover from the mcs blades.The retaining tip cover was observed to be completely detached from the blades.No material appears to be missing.Additional observation not reported by site: the mcs retaining tip cover was found to have a cracking damage.No material appears to be missing.The initial fa findings were confirmed.The mcs tip accessory was returned with the mcs scissor portion separate from the outer grey retaining cover.Inspection of the retaining cover found the cover to exhibit cracking damage visible from the outside of the retaining cover, exterior to where the retaining cover's bayonets reside.Inspection found no missing pieces and both bayonets were still present on the retaining cover and were attached.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
On 09/10/2024, intuitive surgical, inc.(isi) received user facility report (b)(4) stating the following: "tip broke while using in patient.Able to locate and retrieve both pieces.".
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 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: 19957003
• Report Number: 2955842-2024-18090
• Device Sequence Number: 12986026
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(17)251031(10)K10231026
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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: K10231026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 09/10/2024
• Initial Report FDA Received Date: 08/10/2024
• Supplement Report FDA Received Date: 09/10/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown