MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; ATRIAL RETRACTOR SHORT RIGHT

Model Number	470246-09
Medical Device Problem Codes	Material Fragmentation (1261); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the atrial retractor short right (arsr) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The arsr instrument was analyzed and found a broken distal pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.A root cause of the broken pitch cable is associated to a component failure.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.Additional investigation found a derailed grip cable at the distal idler pulley.A root cause of the derailed grip cable is associated with a component failure.Derailed cables are attributed to a loss of cable tension.A cracked clamping pulley and/or input shaft can cause the cable to become dislodged at the proximal end.When the clamping pulley and/or input shaft is cracked, the cable can dislodge as the input could "slip" with respect to its internal shaft causing the loss of cable tension.A cracked clamping pulley and/or input shaft can be caused by improper cleaning or sterilization techniques used during reprocessing.A dislodged cable at the proximal end can then result in the cable becoming derailed or loose at the distal end, which may lead to non-intuitive motion.The instrument was also found to have a frayed grip cable at the distal end.
Event or Problem Description
It was reported that during a da vinci-assisted mitral valve repair surgical procedure, the atrial retractor short right (arsr) instrument could not be opened and closed due to a broken silver cable.The customer used a new arsr instrument to continue with the surgery.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: there was no report of a fragment falling into the patient.

• Brand Name: ENDOWRIST
• Common Device Name: ATRIAL RETRACTOR SHORT RIGHT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17196060
• Report Number: 2955842-2023-16594
• Device Sequence Number: 14863442
• Product Code: NAY
• UDI-Device Identifier: 00886874112397
• UDI-Public: (01)00886874112397(11)210930(10)N10211004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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: 470246-09
• Device Catalogue Number: 470246
• Device Lot Number: N10211004 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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