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

Model Number	430010-57
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon could not control the movement of the single port maryland bipolar forceps instrument.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed and found to have a cracked grip input disk.The input disk controlling the rolling of the instrument appears cracked.The crack was seen on one side of the input disk.The crack on the input disk likely caused imprecise motion during functional testing.A visual inspection was performed and found no external damage to the instrument¿s main tube or distal end.The instrument was found to have failed functional testing with imprecise motion.The imprecise motion was likely caused by the crack found on the grip's input disk.The instrument was installed on an in-house system and driven and passed the recognition and engagement tests.The instrument exhibited imprecise motion during the roll motion.The instrument was found to have corroded pulley cables.When the housing of the instrument was opened up, the pulley cables exhibited white substance.The white substance is indicative of corrosion.If the input disk is fully broken, then the instrument can fail to engage.The issue is immediately detectable by the surgeon due to loss of instrument functionality.The complaint was confirmed by failure analysis.The probable root cause is attributed to use and reprocessing conditions.The input disk can be susceptible to chemical or thermal stresses, which can result in the appearance of cracks in the ultem or peek material.Under repeated or prolonged chemical or thermal exposure cycles, these cracks can propagate into larger cracks and may cause the input disk to break and separate from the instrument.The probable root cause is attributed to improper cleaning or sterilization techniques used in reprocessing, which may include prolonged exposure of the instrument to harsh cleaning agents or insufficient flushing.

• 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: 23482348
• Report Number: 2955842-2025-44045
• Device Sequence Number: 10252480
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(10)U10230302
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: U10230302 0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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