MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; ROUND TIP SCISSORS

Model Number	470007-05
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The round tip scissors instrument was analyzed and found to have a frayed pitch cable at the proximal clevis hub.Some filaments of the cable were frayed, but the cable was not fully broken.The frayed cable strands stuck out at the wrist.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing-induced issue.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.When pitch cable breakage occurs, the instrument is immediately inoperable due to loss of functionality.The instrument has tungsten drive cables to transmit motion from the input discs in the housing, through the main shaft, and to the distal instrument tip.These cables are exposed at the instrument tip and control movements at the wrist.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm round tip scissors instrument's cable broke.It was unknown if a fragment fell into the patient.The procedure and patient outcome are unknown.

• Brand Name: ENDOWRIST
• Common Device Name: ROUND TIP SCISSORS
• 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: 21441986
• Report Number: 2955842-2025-02033
• Device Sequence Number: 4683546
• Product Code: NAY
• UDI-Device Identifier: 00886874112168
• UDI-Public: (01)00886874112168(11)230601(10)K10230601(91)0006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• 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: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: 470007-05
• Device Catalogue Number: 470007
• Device Lot Number: K10230601 0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: ISIFA2024-09-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown