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	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer had difficulty in moving single site fenestrated bipolar forceps instrument.Additionally, the bipolar energy on instrument was not working.The instrument was observed to have a broken cable.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The instrument involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single site fenestrated bipolar forceps instrument to perform failure analysis.Failure analysis investigations confirmed the customer reported complaint.The instrument was analyzed and it was found to have a loose screw on the rocker at the proximal end.The loose screw likely caused the push - pull rob mechanism to fail.Hence, the jaws did not open nor close properly.After tightening the screw, the jaws opened and closed successfully.Additional observation : the instrument was recognized by the test system and it successfully passed all functional tests.Energy delivery was tested and it passed in various grip orientations.The instrument passed an electrical continuity test.The probable root cause of loose screw on instrument is attributed to a component failure.Correction to section d : primary product batch/lot number was updated to k14250123 0048 correction : h8.Was updated to initial use of device.
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: 22928707
• Report Number: 2955842-2025-36129
• Device Sequence Number: 21122643
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)270131(10)K14250123
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: K14250123 0048
• 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: 08/10/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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
• Patient Sex: Unknown