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

Model Number	478093-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the single-site fenestrated bipolar forceps instrument, however, intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted myomectomy surgical procedure, the single-site fenestrated bipolar forceps instrument was found to have the tip broken.The instrument was removed and replaced with a backup.Following this, the user continued and completed the procedure with no further issues.No fragment fell into the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter confirmed that the instrument tip was broken off/detached from the shaft.The reporter clarified that the tip was visibly broken during the procedure, specifically while coagulating a bleeding tissue.The instrument was removed from the patient and no fragment fell into the patient's body.There was no patient injury.There is no report of post-surgical complications, and the patient has not returned to the hospital.The instrument did not collide with any other instruments or other hard material during the procedure.No images or videos are available for isi review.The reporter was unable to disclose the patient demographic information.
Additional Manufacturer Narrative
The single site fenestrated bipolar forceps instrument has been evaluated by the failure analysis (fa) team.Fa was able to confirm/reproduce the reported complaint.During the visual inspection, the instrument was found to have a broken distal clevis on both sides of the ears of the clevis.One of the grips was found to be broken and completely detached from the instrument as result of the distal clevis breakage.The broken and detached pieces were not returned with the instrument.Components adjacent to the broken clevis shows damage.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Instrument collisions with other hand-held instrumentation or instrument driven outside the field of view can also cause damage to the instrument distal clevis.

• 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: 21957982
• Report Number: 2955842-2025-18685
• Device Sequence Number: 7265631
• Product Code: NAY
• UDI-Device Identifier: 00886874113738
• UDI-Public: (01)00886874113738(17)260930(10)K10240902
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: K10240902 0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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: Reuse
• 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: Female