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	Foreign Body In Patient (2687)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the atrial retractor short right (arsr) instrument cable was ¿dropped out.¿ the fragment was retrieved in different procedure.An x-ray test was performed.The procedure was completed as planned.There was no patient injury.Intuitive surgical (isi) followed up with the initial reporter and obtained additional information.The cable was loose.The customer stated that instrument did not move correctly at the beginning of the procedure.The customer felt resistance when removing the instrument through the cannula.The incision was closed before the fragment was identified; therefore, the surgeon had to reopen the incision to remove the fragment.The customer confirmed that all fragments were removed upon visual and x-ray inspection.The customer stated that there was no patient injury.The fragment will not be returned.
Additional Manufacturer Narrative
Intuitive surgical (isi) has received the atrial retractor short right (arsr) instrument; however, failure analysis has not completed their investigation.Therefore, the root cause of the customer reported failure mode could not be determined.
Additional Manufacturer Narrative
The atrial retractor short right instrument has been evaluated by the failure analysis (fa) team.The instrument was found to have a broken pitch cable at the proximal clevis hole.The broken cable segment that contains the crimp one was missing from in the clevis.The cable was fully broken.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The atrial retractor short right instrument was transferred to the failure analysis engineering team for further investigation.Initial findings were confirmed.The pitch cable was found to be broken and a part of the cable, approximately 0.215 inches in length, along with one crimp was found to be missing.The broken end had retracted into the main tube.

• Brand Name: ENDOWRIST
• Common Device Name: ATRIAL RETRACTOR SHORT RIGHT
• 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: 20139259
• Report Number: 2955842-2024-18766
• Device Sequence Number: 7482348
• Product Code: NAY
• UDI-Device Identifier: 00886874112397
• UDI-Public: (01)00886874112397(11)230615(10)K10230615
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470246-09
• Device Catalogue Number: 470246
• Device Lot Number: K10230615 0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 10/17/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/20/2024; 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose