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	Foreign Body In Patient (2687)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted nipple sparing mastectomy surgical procedure, the customer indicated that the 1st monopolar curved scissors (mcs) tip accessory seemed to be loose and shaking when using with the sp mcs instrument.The customer removed the instrument and replaced the mcs tip; however, the 2nd mcs tip became separated upon inserting.Some pieces from the instrument and the mcs tip were broken and fell into the patient.The customer was able to retrieve some fragments and completed the procedure with a backup instrument and a 3rd mcs tip.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument and accessories were inspected prior to use, and no damage was identified.The customer retrieved all fragments during same procedure and performed frequent irrigation.Post-operative tests were not performed.The 2nd mcs tip accessory had physical damage after the event occurred even though the mcs instrument did not collide with any other instruments during the surgical procedure.The mcs tip accessories appeared to be properly installed.There was no difficulty in removing the instrument and mcs tip accessories and the instrument wrist was straightened upon removal.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.In addition, the 1st mcs tip accessory was found with no damage and the event did not result in patient injury.There any report of fragments falling from the 1st mcs tip while used within a patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The monopolar curved scissors (mcs) tip accessory was returned and failure analysis testing was performed.Visual inspection was performed, and the mcs tip accessory was found to have a broken retaining tip cover.No material appeared to be missing.The instrument was found to have multiple indentations at the tip of the accessory tips.The tips were not bent.No missing material was observed.

• 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: 19812567
• Report Number: 2955842-2024-17356
• Device Sequence Number: 18313857
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(17)251130(10)K10231102
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2024

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: K10231102
• 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: 06/30/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: Female