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	Insufficient Information (4580)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 6mm maryland bipolar forceps instrument to perform failure analysis.The instrument was analyzed and found to have a broken roll input disk inside the housing.Other backend components adjacent to the broken inputs did not show damage.The instrument was installed on an in-house system and driven.Instrument exhibited imprecise motion in the closing of the grip tips.The grip tips moved in the direction commanded; however, the grip tips are unable to close fully.This failure is likely due to the broken input disk observed.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 probable root cause of the broken instrument input disks is attributed to use and improper reprocessing conditions.The input disk component is made of ultem or peek material, insert-molded over a steel pin.The insert molding process creates residual stresses in the input disk, which can make it susceptible to chemical or thermal stresses.These stresses may lead to the formation of cracks in the ultem or peek material.With repeated or prolonged chemical or thermal exposure cycles, such cracks can propagate and result in the input disk breaking and detaching from the instrument.The broken input disk contributed to the imprecise motion.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.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer experienced reverse movement on the patient side manipulators (psm) and with single-port (sp) maryland bipolar forceps (mbf) instrument.The issue always started at the beginning of the procedure, and it was not due to a camera issue.The customer replaced the instrument to resolve the issue.The customer stated that they were in the process of reseating the endoscope and may exchange it.The procedure was completed with no reported injury.

• 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: 22867701
• Report Number: 2955842-2025-34490
• Device Sequence Number: 9258024
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(10)U11220607
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: U11220607 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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: Reuse
• 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