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

Model Number	470246-09
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the short right atrial retractor instrument involved with this complaint and completed the device evaluation.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was missing from the clevis.Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.A review of the instrument log for the short right atrial retractor instrument (part # 470246-09 / lot # n10210823-0005 associated with this event shows that the instrument was last used on (b)(6) 2022 on system (b)(4) for a mitral valve repair surgical procedure.The instrument had 7 uses remaining.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: failure analysis found the short right atrial retractor instrument to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from the clevis.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could potentially fall inside a patient.Although there was no patient injury reported, a recurrence of the failure mode could cause or contribute to an adverse event.
Event or Problem Description
It was reported during a da vinci-assisted mitral valve repair surgical procedure, the short right atrial retractor instrument had a broken cable.The procedure was completed as planned with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) obtained the following information from the initial reporter about the complaint: the instrument was inspected prior to last use and no issues were identified.It is unknown if there were any instrument collisions at the time of use.It is unknown if the patient returned due to any post-operative complications.

• 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: 14950859
• Report Number: 2955842-2022-12825
• Device Sequence Number: 17485934
• Product Code: NAY
• UDI-Device Identifier: 00886874112397
• UDI-Public: (01)00886874112397(11)210819(10)N10210823
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/07/2022

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: N10210823 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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