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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, fenestrated bipolar forceps plastic of the tip was broken, and a fragment fell inside of the patient, the fragment was retrieved during the same procedure.The procedure was converted to laparoscope surgery.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and no issue was noted.The instrument was in use for more than 10 minutes.The tip was not moved well so the customer confirmed the instrument and found a crack.The instrument was removed with the cannula.The instrument fully broke during reprocessing.The instrument did not collide with any other instruments or other hard materials during a surgical procedure.The fragment did not fall inside of the patient during instrument tip or accessory collision.Upon final removal of the instrument, the instrument was removed with the cannula.No fragments fell inside the patient.The procedure was converted to laparoscopic surgery and fenestrated bipolar forceps were used.No additional ports were placed or port incisions increased.No injury was reported.The patient did not return to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The instrument is available for return.
Additional Manufacturer Narrative
The event investigation is in progress.An return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
Updated sections: d9, h3, annex codes: g, b, c, d device evaluation: intuitive surgical, inc.(isi) did receive the fenestrated bipolar forceps instrument to perform failure analysis (fa) and was able to confirm and replicate the customer reported complaint.The instrument was found to have a broken distal clevis at the base of the clevis.The broken piece was not returned, measuring roughly 0.0770# x 0.1515# in size.The clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis do not show damage.

• 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: 21407986
• Report Number: 2955842-2025-01790
• Device Sequence Number: 15507632
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)260731(10)K10240725
• 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): 01/20/2025

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: K10240725 0039
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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: 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