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

Model Number	470246-09
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The atrial retractor short right instrument was analyzed and failure analysis investigations replicated/confirmed the customer reported complaint.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was not in the clevis.An additional observation not reported by the site was also identified.The atrial retractor short right instrument was found to have an excessive amount of dried residue around the clamping pulleys.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci assisted mitral valve repair surgical procedure, the atrial retractor short right instrument would not open.A backup instrument was used to complete the procedure with no patient harm.

• 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: 17762238
• Report Number: 2955842-2023-18504
• Device Sequence Number: 7210670
• Product Code: NAY
• UDI-Device Identifier: 00886874112397
• UDI-Public: (01)00886874112397(10)N10190722
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2023

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: N10190722 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2023
• Initial Report FDA Received Date: 09/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2019
• 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