MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LONG TIP FORCEPS

Model Number	471048-09
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested that the long tip forceps be returned for failure analysis investigation.Isi has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during central processing, the wire was exposed.There was no report of patient involvement.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The long tip forceps instrument was analyzed and found to have a broken grip cable at the proximal end within the housing.The grip cable was fully broken at the clamping pulley.There was no discoloration, corrosion, or contamination on the cable to suggest improper reprocessing as a contributing factor.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.Additional observation(s) not reported by site: the instrument was found to have a loose grip cable at the yaw pulley.Common causes of broken - proximal instrument grip cables are attributed to damage to the cable during use or during reprocessing.Common causes of loose instrument grip cables are often attributed to a cracked clamping pulley, which can lead to cable dislodgement at the proximal end, resulting in a lack of tension and a loose or dislodged cable at the distal end.Such cracks in pulleys, shafts, and disks within the housing typically occur due to improper reprocessing conditions.

• Brand Name: ENDOWRIST
• Common Device Name: LONG TIP 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: 21972321
• Report Number: 2955842-2025-19302
• Device Sequence Number: 8160783
• Product Code: NAY
• UDI-Device Identifier: 00886874121467
• UDI-Public: (01)00886874121467(11)231123(10)K10231123(91)0001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 471048-09
• Device Catalogue Number: 471048
• Device Lot Number: K10231123 0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/31/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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