MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CAUTERY INSTRUMENT

Model Number	430007-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, single port (sp) monopolar cautery instrument hook tip was not moving properly.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) received the following additional information: the surgical procedure being performed was a urology procedure.The event date was (b)(6).The ports were placed prior to the issue being identified.The instrument moved in the wrong direction.The intended movement was left and the observed movement was right.Th issue occurred when the surgeon was attempting to manipulate instruments from the surgeon console.The issue was persistent.A backup instrument was used.No drape is available for return.There was no patient injury.The device was inspected prior to use.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 6mm monopolar cautery instrument for failure analysis investigation.The instrument was analyzed and found to have imprecise motion during in-house testing.Prior to in-house testing, a hook tip accessory was installed.The instrument was installed on an in-house system and driven.Although, the instrument moved intuitively with full range of motion in almost all directions, while manipulating the mtm (master tool manipulator) the instrument failed pitch.Please note that while manually articulating the distal end the tip felt tension free.Visual inspection was performed and found no external damage to the snake wrist cables or housing.All input disks other than 'pitch' articulated without issues.The complaint was confirmed by failure analysis.Additional observation(s) not reported by site: the instrument was found to have frayed cables at the distal end.To clarify, the wrist control cable located at the distal end appeared intact but frayed.The instrument was found to have a loose pitch cable in the housing.When the housing was opened up for inspection, the cables on the pitch pulley did not appear taut.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.The instrument was found to have corroded bearings.Input disk bearing exhibit orange discoloration.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the single port (sp) monopolar cautery instrument for failure analysis investigation.The instrument was analyzed and initial fa was confirmed, the instrument exhibited imprecise motion.When installed on an in-house system, it was observed that the instrument would mostly follow the master tool manipulator (mtm) commands in most orientations, but when rolling the instrument, it was observed that in one particular position the instrument would not pitch up or down as commanded, as the instrument's tip would not pitch up or down.In addition, the sp monopolar cautery instrument was found to have a loose wrist control cable, and the cable was in the location where if this cable was upwards the instrument would not pitch up or down as expected.The cable did not appear to be frayed, and the cable was intact.A gentle pull test found that the instrument's crimps were intact as the cable did not pull freely.The wrist control cable was observed to be loose from the instrument's snake wrist all the way to the proximal end, as the cable appeared loo on the pulley.A loose wrist control cable could lead to the observed pitch issues, as the cable is no longer under tension and cannot pull the instrument's wrist as expected.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CAUTERY INSTRUMENT
• 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: 23909215
• Report Number: 2955842-2025-49597
• Device Sequence Number: 18647905
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(11)250227(10)K10250227
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

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: 430007-62
• Device Catalogue Number: 430007
• Device Lot Number: K10250227 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 03/17/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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