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	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested that the fenestrated bipolar forceps be returned for failure analysis investigation.Isi has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that the fenestrated bipolar forceps instrument had an exposed wire at the tip.The customer reported event has no report of patient injury.The reoccurrence of the alleged failure mode would not cause nor contribute to an adverse event or serious injury.On (b)(6) 2025, intuitive surgical, inc.(isi) received user facility report (b)(4) stating: wire exposed at the end of the fenestrated bipolar forceps (seen on the camera).Isi followed up with the initial reporter and obtained the following additional information: the issue was first observed intraoperatively.It was unknown if the wire was exposed due to damaged insulation.The cable was intact, the scissor tip cover was split on the sides.There was no loss of cautery associated with the damaged cable.It is unknown if there were any signs of thermal damage.No arcing was observed during the procedure.The procedure was completed with the same instrument, but a new scissor tip cover was replaced.No fragment fell inside the patient.The instrument appeared to be intact and was able to be used with new scissors tip accessory.There were no instrument collisions that occurred during the procedure.There was no issue removing the instrument or tool during the procedure.No photographic images are available.

• 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: 21271008
• Report Number: 2955842-2025-00982
• Device Sequence Number: 11741338
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: N/A N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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: Unknown