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

Model Number	430010-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port maryland bipolar forceps to perform failure analysis.Visual inspection was performed and the instrument was observed to have a broken lower molded insulator.The broken piece measures approximately 4.3mm x 15mm and was not returned with the instrument.The broken lower molded insulator was the likely cause of the detached fragment and broken conductor wire.Additionally, lower grip tip was detached from the instrument.The grip base for the grip with the cracked molded insulator does appear bent and slightly twisted.There was no external damage to the shaft, housing, and snake wrist cables.Each input disk was manually articulated and responded accordingly.The release buttons were functional.Common causes of the failure mode broken molded insulator can result from mechanical impact or excessive force applied to the jaws, such as an accidental drop of the instrument.Additional observation(s) related to the customer reported complaint: the instrument was found to have a broken conductor wire.Visual inspection was performed and the instrument was observed to have a broken conductor wire located near the distal tip.The broken conductor wire was likely caused by the broken lower molded insulator.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the tip broke at the jaw of the single port maryland bipolar forceps instrument.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the damage occurred outside of the surgical procedure.There was no report of fragments falling from the device while used within the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications.There was no material missing or detached from the instrument.

• 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: 24868201
• Report Number: 2955842-2026-21418
• Device Sequence Number: 18649211
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(11)250702(10)K10250702
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 430010-62
• Device Catalogue Number: 430010
• Device Lot Number: K10250702 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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