MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MARYLAND BIPOLAR FORCEPS

Model Number	430010-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the console surgeon found the tip was broken and the insulator plastic part was found to be detached.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The bipolar instrument was analyzed and found to have a broken molded insulator.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Additional observations related to the reported symptom detail: the instrument was found to have a detached fragment.The missing piece measures approximately 16.5mm x 4.28mm, confirming that the fragment detached from the instrument and was not returned with the instrument.For clarification the detached fragment is the missing uppr grip.Common causes of the failure detached fragment can result from mechanical impact or excessive force applied to the jaws, such as an accidental drop of the instrument.The instrument was found to have a broken conductor wire near the partial cut out of the electrode: within the grip base.No thermal damage was found on the instrument.Common causes of broken instrument conductor wire -bipolar include instrument movements, such as grasping, pulling, or pitching, which can cause the grip to become dislocated or dislodged, and potentially pull the conductor wire out of the routing groove.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MARYLAND 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: 23811340
• Report Number: 2955842-2025-48654
• Device Sequence Number: 9389643
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(11)240222(10)K10240222
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 430010-57
• Device Catalogue Number: 430010
• Device Lot Number: K10240222 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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