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

Model Number	478093-03
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	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the 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.A review of the provided image was performed by an isi clinical development engineer.The following additional information was provided: because of the damaged wrist and clevis, there is a potential for tissue to be caught or damaged.The user may also experience unintuitive motion due to the jaw breakage.A review of the provided image was performed by an isi failure analysis engineer.The following additional information was provided: it appears that the clevis ear is broken.The root cause of the failure mode cannot be confirmed prior to the return and analysis of the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the user noticed that the fenestrated bipolar forceps's jaws were twisted and misaligned.The user confirmed no tissue was caught when the issue occurred.The instrument was removed together with the cannula due to the misaligned jaws.The instrument was removed and replaced with a backup.Following this, the user continued with the procedure with no further issues.No fragment fell into the patient.No known impact or patient consequence was reported.A procedure delay of 15 minutes was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the user confirmed that the event date was (b)(6) 2025, the port incision was not increased in order to remove the instrument and cannula together.The reporter was unable to disclose the patient demographic information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the fenestrated bipolar forceps instrument to perform failure analysis.The instrument was found to have a broken distal clevis at the base of the clevis.The broken piece was returned, measuring roughly 0.2255¿ x 0.0405¿ in size.Clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis show damage which may indicate potential mishandling/misuse.The clevis pin is missing.Additional observation related to customer reported complaint: distal clevis pin on the distal end is visibly missing.The missing pin was not returned with the instrument.This is caused by the broken distal clevis.The complaint was confirmed by failure analysis.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: 21916440
• Report Number: 2955842-2025-17308
• Device Sequence Number: 18413591
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)260831(10)K10240808
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: K10240808 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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