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

Model Number	430035-11
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single port (sp) monopolar curved scissors (mcs) instrument and tip were received for evaluation and the testing was completed.The accessory was found to be dislodged.From the mcs blades.Both components were returned.The retaining tip cover was reseated on the blades and placed on an in-house sp msc instrument.The cover was found to rotate past the grooves of the tube adapter freely.The instrument and tip accessory were then placed on the in-house system and failed tip recognition.
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the single port (sp) monopolar curved scissors (mcs) instrument tip came off.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the sp mcs was inspected prior to use with no issue.The sp mcs tip came off outside the patient¿s anatomy.There was no fragment falling into the patient.The patient did not return to the hospital for any post-surgical complications.Only the tip of the sp mcs was returned.
Additional Manufacturer Narrative
Additional analysis was performed on the monopolar curved scissors (mcs) tip by an advanced failure analysis engineer.The initial finding was confirmed.The accessory was installed on an in-house instrument and as found in the initial findings, the retaining cover could freely spin and did not engage with the grooves on the in-house instrument's instrument tube adapter.The monopolar curved scissors (mcs) instrument was installed onto the in-house system with the tip accessory installed and it was noticed that the retaining cover became dislodged, but did not freely fall, from the instrument's tube adapter.The system raised a tip detection error as the system was unable to detect the accessory since it was unable to properly lock onto the instrument tube adapter.It was found that the silicone retaining cover of the mcs tip accessory exhibited damage on both of the retaining bayonets.Due to the damaged bayonets, they were unable to retain the cover and the tip accessory to the instrument's tube adapter, and manually actuating the grip knob would cause the tip accessory to raise and dislodge, but not fall off as the scissor component was still engaged.Damage to the retaining cover of the instrument tip accessory is typically attributed to mishandling.
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: 17195406
• Report Number: 2955842-2023-16575
• Device Sequence Number: 7360280
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(10)K10221006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: K10221006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/27/2023
• 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: Male