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

Model Number	478080-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy procedure, a fragment from a bipolar maryland instrument broke off and fell inside the patient.The cause of the fragment detaching is unknown.Fortunately, the fragment was retrieved during the same procedure and its complete retrieval was visually confirmed.No additional surgical procedures were required to remove the fragment, nor were any post-operative tests, such as x-rays or ultrasounds, conducted to check for remaining fragments.The procedure was successfully completed robotically.A backup bipolar maryland instrument was used to complete the procedure.The patient has not returned to the hospital due to any post-surgical complications.
Additional Manufacturer Narrative
The bipolar maryland instrument has not been returned for failure analysis.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The single site bipolar maryland instrument was analyzed and found to have a broken proximal clevis at the ears of the clevis.The broken pieces were not returned, measuring roughly 0.3045¿ x 0.0670¿ in sizes.The clevis did not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis did not show damage.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: BIPOLAR MARYLAND
• 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: 22998469
• Report Number: 2955842-2025-37228
• Device Sequence Number: 9090001
• Product Code: NAY
• UDI-Device Identifier: 00886874113707
• UDI-Public: (01)00886874113707(17)270131(10)K10250109
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• 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): 12/01/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 478080-03
• Device Catalogue Number: 478080
• Device Lot Number: K10250109 0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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: Unknown
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown