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

Model Number	430035-11
Medical Device Problem Code	Material Integrity Problem (2978)
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 has received themonopolar curved scissors (mcs) tip accessory associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint of "locking part extruded and tip was separated from the instrument".The monopolar curved scissors (mcs) tip accessory was installed onto an in-house instrument and it was found that the disposable retaining cover was able to freely rotate on the instrument's instrument tube adapter.Because the cover is able to freely rotate, the tip accessory as a whole was unable to fully secure onto the instrument tube adapter.Both retaining lances of the tip cover were found damaged.From the outside view, the retaining lances were seen bulging outwards, indicating excessive wear or over-rotating the mcs tip accessory during installation in attempts to get the tip accessory to fit.
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal prostatectomy w/o lymphadenectomy surgical procedure, the user observed that the transparent part of the sp monopolar curved scissors (mcs) instrument tip was torn and could not be connected to the instrument.There was no report of fragment(s) falling inside the patient.The procedure was continued.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 found.A pin gauge was used to inspect the cannula.The customer indicated that arcing was not observed.The sp mcs tip accessory appeared to be properly installed and did not collide with any other instrument or tool during the surgical procedure.The issue was identified during dissection and the cadiere forceps and maryland bipolar forceps instrument were in use.There was no report of fragment(s) fell inside of the patient.A backup product was used to continue the procedure and there was no patient injury/harm.The instrument had no physical damage and would not be returned to isi for evaluation.

• 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: 19194821
• Report Number: 2955842-2024-13618
• Device Sequence Number: 18046455
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(17)250430(10)K10230413
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: K10230413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: Unknown
• 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