MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CURVED SCISSORS ER

Model Number	431100-01
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	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal with lymphadenectomy prostatectomy procedure, the customer observed non-intuitive motion with patient side manipulator (psm) #2.There was an intra-operative collision and the monopolar curved scissors (mcs) instrument broke.A fragment fell inside the patient but was retrieved during the same surgical procedure.The customer reseated the instrument on psm #2 and intuitive motion returned.The procedure was completed robotically on 12-dec-2025, intuitive surgical, inc.(isi) received the following additional information regarding the event: the surgeon believes that the breakage of the mcs instrument occurred due to a collision with a cadiere forceps instrument, which was not responding properly at the time.The fragments were retrieved by the surgical team.No additional surgical procedure was required to retrieve the fragments.No post-operative tests such as x-rays or ultrasounds were performed to check for remaining fragments, as the surgical team was confident that complete retrieval had occurred.The procedure was completed robotically.
Additional Manufacturer Narrative
The monopolar curved scissors (mcs) instrument has not been received for failure analysis evaluation.A review of an image provided by the customer was performed and the following additional information was provided: the sp mcs instrument in the image provided appears to have a broken instrument tube adapter.The tip may have abrasions as well, but it is difficult to say for sure from the image provided.Note: refer to medwatch report (mdr) with mfr.Report #2955842-2025-50194 for mdr submission of the reported non-intuitive motion experienced by the customer involving the psm.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) instrument was analyzed and found to have a broken instrument tube adapter.This component is located at the distal end of the instrument and serves as the interface between the instrument and the user installed tip accessory.The broken piece was not returned and would have measured approximately 3.11 mm x 1.75 mm.The broken tip adapter made it difficult to install a tip and caused the tip to not be securely attached.An in-house mcs tip was installed onto the instrument prior to inhouse testing.When placed on the in-house system, the instrument passed engagement and recognition.Both cut and cautery initiated without any issues.Electrical continuity was tested using a multimeter.One of the probes was on an instrument pin and the other was at the distal tip.The multimeter was audible indicating a flow in electricity.Visual inspection was performed and found no external damage on the housing.The housing was removed for inspection and found no internal damages.All input disks articulated without any issues.Additional finding(s) related to the customer reported complaint: the instrument was found to have detached fragments.The fragments were not returned and was likely caused by the broken instrument tube adapter.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CURVED SCISSORS ER
• 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: 23989800
• Report Number: 2955842-2025-50195
• Device Sequence Number: 10184982
• Product Code: NAY
• UDI-Device Identifier: 00886874124048
• UDI-Public: (01)00886874124048(10)K10250213
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• 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): 02/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 431100-01
• Device Catalogue Number: 431100
• Device Lot Number: K10250213 0004
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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