MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; CANNULA, STANDARD, REUSABLE

Model Number	470002-08
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the cannula to perform failure analysis.The cannula was analyzed and found to have scratch mark damage at the distal end of the cannula.The scratch marks were located inside of the dark grey ink strip at the bottom of the cannula.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Isi also received the vessel sealer extend (vse) instrument to perform failure analysis.The instrument was analyzed and found to have scratches on the main tube.The instrument was found to have various scratch marks with light material removed on the main tube.The instrument was returned with the cord cut so the instrument was not able to be tested for sealing/cutting functionality.The instrument was placed on an in-house system and passed recognition and engagement tests and moved intuitively through a full range of motion in all directions.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.A separate medwatch report (mdr) with mfr report #2955842-2024-24002 was submitted for the vessel sealer extend (vse) instrument metal shavings that had come off inside the patient and x-ray that was performed.
Event or Problem Description
It was reported that during a da vinci-assisted paraesophageal hiatal hernia repair procedure, the coating/metal shavings on shaft of the vessel sealer extend (vse) instrument scraped off and fell inside the patient's abdomen.The intuitive surgical, inc.(isi) customer sales representative (csr) that was present during the procedure stated that the surgeon was able to remove most of the metal shavings.It is unknown if all the shavings were retrieved.A post operative x-ray was performed but the results of the x-ray are unknown.The surgeon reported that the patient has not returned with any post-operative complications.

• Brand Name: DA VINCI
• Common Device Name: CANNULA, STANDARD, REUSABLE
• 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: 21461411
• Report Number: 2955842-2025-01726
• Device Sequence Number: 18090874
• Product Code: NAY
• UDI-Device Identifier: 00886874112137
• UDI-Public: (01)00886874112137(10)VE200701
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: 470002-08
• Device Catalogue Number: 470002
• Device Lot Number: VE200701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2020
• 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: Unknown
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White