MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; FENESTRATED BIPOLAR FORCEPS

Model Number	478093-03
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the fenestrated bipolar forceps had a damaged wire.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the nurse and obtained the following additional information: the customer reported that the full lot number of the instrument was unknown.The customer clarified that the issue with the instrument was that it had a damaged wire.The customer confirmed that the instrument was inspected prior to use and found the wire damage prior to use.There was no patient injury as a result of the instrument issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single site fenestrated bipolar forceps instrument to perform failure analysis.Failure analysis investigations did not confirm the customer reported complaint.The instrument was analyzed and it was found to be fully functional.The instrument did not have any damaged cables.The instrument had a broken input shaft causing the instrument to fail the engagement.Additional observation: the instrument yaw inputs failed to engage with the in-house system's sterile adapter during all attempts.The probable root cause of broken input shaft is attributed to damage during reprocessing.Leftover residual chemicals on the input shaft can result in cracking at high temperatures of the autoclave.Insufficient flushing/rinsing steps at the end of the cleaning process can also result in a damaged instrument input shaft.Once the instrument is recognized on the da vinci system, engagement gets checked.The engagement sequence runs for each installation of the instrument to ensure proper mating and transmission of force between usm carriage outputs, instrument sterile adapter, and instrument input disks.Successful engagement is detected by driving the instrument sterile adapter through a predefined trajectory.The probable root cause of engagement failures is attributed to an over-constrained design condition between the mating parts of the instrument and instrument sterile adapter disks.Correction to section d: - primary product batch/lot number was updated to k10250612 0051.- primary product udi number was updated to (b)(4).
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: FENESTRATED BIPOLAR FORCEPS
• 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: 23206481
• Report Number: 2955842-2025-40230
• Device Sequence Number: 9278641
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)270630(10)K10250612
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478093-03
• Device Catalogue Number: 478093
• Device Lot Number: K10250612 0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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: Unknown