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	09/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed and found to have a broken molded insulator on the lower jaw.The broken piece measures approximately 0.81mm x 1.90mm and was not returned with the instrument.The grip base for the grip with the cracked molded insulator does not appear to be bent.Additionally, the instrument was found to have a detached fragment.The fragment broken off from the instruments molded insulator.The broken piece was not returned.The instrument was found to have thermal damage on the molded insulator.The thermal damage was found around the area where the molded insulator was broken.The instrument passed an electrical continuity test the complaint regarding plastic around the distal tip is broken was confirmed by failure analysis.The probable root cause of a broken molded insulator can result from mechanical impact or excessive force applied to the jaws, such as an accidental drop of the instrument.The probable root cause of thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.
Event or Problem Description
It was reported that the maryland bipolar forceps instrument was tagged and the plastic around the distal tip was broken.The procedure outcome is unknown at the time of the report.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: upon review of the provided responses, the reporter confirmed that the tip was not broken off or detached from the tube adapter, and there was no damage or missing part observed on the adapter.Additionally, no scratch marks or abrasions were noted.The last use of the instrument was during a partial nephrectomy procedure on (b)(6), 2025, on system sp0262, but it is unknown whether any fragments fell into the patient or if post-operative imaging was conducted to check for remaining fragments.The issue was identified by the spd technician after the procedure, and there was no report of patient injury.The reporter further indicated that how the procedure was completed and whether the instrument collided with other instruments or hard materials during surgery is unknown.

• 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: 23343120
• Report Number: 2955842-2025-42391
• Device Sequence Number: 12698454
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(11)230927(10)U10230927
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2025

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: 430010-57
• Device Catalogue Number: 430010
• Device Lot Number: U10230927 0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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