MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CARDIAC PROBE GRASPER

Model Number	470215-09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the cardiac probe grasper instrument for evaluation, but evaluation has not been completed as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the cardiac probe grasper instrument was found to have a broken cable.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 cardiac probe grasper instrument was analyzed and found input disk seven to be broken and completely detached from the base.The missing wheel was returned with the instrument.Other backend components adjacent to the broken input do not show damage.The complaint was confirmed by failure analysis.The probable root cause is attributed to use and reprocessing conditions.The input disk component consists of ultem or peek material insert molded over a steel pin.The insert molding process results in residual stress in the plastic portion of the input disk.These residual stresses 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.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: CARDIAC PROBE GRASPER
• 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: 21301172
• Report Number: 2955842-2025-01130
• Device Sequence Number: 12987547
• Product Code: NAY
• UDI-Device Identifier: 00886874112373
• UDI-Public: (01)00886874112373(11)230310(10)K10230310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 470215-09
• Device Catalogue Number: 470215
• Device Lot Number: K10230310 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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: 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