MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; CADIERE FORCEPS

Model Number	420049-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and found to have a broken grip that is completely detached from its base.The broken piece was not returned with the instrument.Components adjacent to this broken grip do not show damage.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted mediastinal mass resection surgical procedure, the cadiere forceps had a broken tip.The instrument still had a life.The procedure was completed with no reported injury.No fragment fell into the patient.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information: the incident occurred during surgery, but no fragments of the material were lost and no harm was done to the patient.There have been no reports of fragments falling from the device during use.No action was taken as no fragments fell during use.The surgery was completed successfully and there were no complications in the post-operative period.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: CADIERE 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: 21567688
• Report Number: 2955842-2025-06799
• Device Sequence Number: 21233040
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10210104
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2025

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: 420049-13
• Device Catalogue Number: 420049
• Device Lot Number: N10210104 761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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