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

Model Number	430010-57
Medical Device Problem Code	No Device Output (1435)
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
Correction - h8 updated to indicate initial use of device intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed and found the instrument was installed on an in-house system and passed engagement and recognition without any issues observed.The instrument was able to be advanced through the cannula and moved intuitively across its range of motion.Additionally, a bipolar cautery cable was connected to the instrument and the in-house generator, and no errors were observed.The instrument passed energy recognition and was able to deliver energy as expected when commanded.Additionally, the instrument's housing was opened to inspect the instrument's internals and the rfid board appeared to be in its expected location.The complaint regarding the instrument was not recognized was confirmed by failure analysis.The root cause of the recognition error found in the log is not determinable.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the maryland bipolar forceps instrument was not recognized the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: no thermal damage was observed.No arcing was observed.There was no injury to the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The 6mm maryland bipolar forceps instrument was analyzed and found to have thermal damage on the molded insulator of the grip tip.Electrical continuity test was performed and passed.The complaint regarding instrument not being recognized was not confirmed by failure analysis.Common causes of thermal damage to the molded insulator of the grip tip is attributed to conditions during use.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

• 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: 22820777
• Report Number: 2955842-2025-34544
• Device Sequence Number: 14894444
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(10)U10231122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/24/2025

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: U10231122 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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