MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; CANNULA SEAL

Model Number	470361-08
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product associated with this complaint to perform failure analysis (fa).The cannula seal accessory has been returned and evaluated by fa.Fa investigation did not replicate or confirm the customer reported complaint.Visual inspection displayed no signs of physical damage.The seal was placed on an in-house cannula and an in-house harmonic ace was attached to the system.The instrument attached to and removed from the system, inserting through the seal, without any issues on 2 of 2 attempts.Excessive bio was observed.No product issue was identified.The complaint was not confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure the cannula seal accessory was too tight that it got stucked the harmonic ace.The procedure was completed with no reported injury.On 7/17/2024, isi followed up with the customer and gathered the following information: the instrument and cannula did not need to be removed together but the customer tried so hard to remove it and spent a lot of time.There was a pin sticking out.No fragment fell inside the patient.Port incision size was not increased.The instrument was inspected prior to use and appeared normal.
Additional Manufacturer Narrative
Follow up was performed with the customer and additional information was obtained.It was confirmed the instrument associated with this complaint and used with the cannula seal was a medium/large clip applier and not a harmonic ace instrument as previously reported.Refer to mfr report number 2955842-2024-17537 for details related to the medium/large clip applier instrument.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: CANNULA SEAL
• 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: 19813610
• Report Number: 2955842-2024-17378
• Device Sequence Number: 21014641
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)K12231123
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133845
• 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,Followup
• Report Date (Section B): 06/30/2024

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: Other
• Device Model Number: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: K12231123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Prefer Not To Disclose