MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; DUAL BLADE RETRACTOR

Model Number	470249-09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted mitral valve repair surgical procedure, the 8mm dual blade retractor instrument had a loose wire.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 and the complaint was confirmed.The dual blade retractor instrument was analyzed and found to had a fully broken distal pitch cable at the proximal clevis hub and the broken cable segment that contains the crimp was still installed in the clevis.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing-induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.

• Brand Name: ENDOWRIST
• Common Device Name: DUAL BLADE RETRACTOR
• 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: 21121634
• Report Number: 2955842-2025-00310
• Device Sequence Number: 15664089
• Product Code: NAY
• UDI-Device Identifier: 00886874112403
• UDI-Public: (01)00886874112403(10)N10190917
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: 470249-09
• Device Catalogue Number: 470249
• Device Lot Number: N10190917 0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• 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