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

Model Number	478080-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted ovarian cystectomy surgical procedure, the tip of the single site bipolar maryland forceps instrument was broken.The instrument was removed and replaced with a backup.Following this, the user continued and completed the procedure with no further issues.No fragment fell into the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter confirmed that the tip was broken off/detached from the shaft.There was no patient injury.The instrument did not collide with any other instruments or other hard material during the surgical procedure.No images or video recordings were available for isi review.The reporter was unable to disclose the patient demographic information.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the single site bipolar maryland 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.
Additional Manufacturer Narrative
The single site bipolar maryland forceps instrument has been evaluated by the failure analysis (fa) team.Fa was able to confirm/reproduce the reported complaint.The instrument was found to have a completely broken grip tip.A piece approximately 0.6265 x 0.1475" was found to be broken off.The broken piece was returned with the instrument.Components adjacent to this broken grip do not show damage.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal.
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: 22359054
• Report Number: 2955842-2025-27930
• Device Sequence Number: 12775696
• Product Code: NAY
• UDI-Device Identifier: 00886874113707
• UDI-Public: (01)00886874113707(17)260930(10)K10240905
• 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): 06/04/2025

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: 478080-03
• Device Catalogue Number: 478080
• Device Lot Number: K10240905 0045
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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: Female