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

Model Number	478093-03
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed, and failure analysis investigations replicated and confirmed the customer-reported complaint.The instrument was found to have a torn pet shrink tube at the distal end, with pieces missing.The missing fragments measure approximately 0.2000 x 0.1160 inches.The complaint was confirmed by failure analysis.The probable root cause of torn shrink tube and detached fragment is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure that the tip of the fenestrated bipolar forceps (fbf) instrument would not detach from the cannula during removal.The instrument was extracted using the removal key.The front tip of the instrument was broken off in the process of separating the instrument from the cannula.There were no reports of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there is no report of a fragment falling into the patient's anatomy and also the patient did not returned to the hospital due to experiencing any post-surgical complications related to retention of foreign material.

• 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: 22813192
• Report Number: 2955842-2025-34501
• Device Sequence Number: 5713013
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)260930(10)K10240905
• 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
• Report Date (Section B): 07/23/2025

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: K10240905 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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: Unknown