MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI X/XI ACCESSORY; CANNULA SEAL

Model Number	470361-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received cannula seal accessory involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint "inner seal broke off".The seal was found to have the septum seal torn.The torn piece measures approximately 0.375" x 0.386" and was returned with the seal.The torn piece of the seal was found to have an unknown metal clip attached to it.This complaint is being classified as a reportable event due to the following conclusion: during a da vinci-assisted surgical procedure, the inner seal of the cannula seal accessory allegedly broke off and fell inside the patient.All fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.While there was no harm or injury to the patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.System log review: although a part and a lot number were provided, the cannula seal involved in this complaint is an accessory and does not show in the logs.Site history review: a review of the site's complaint history does not show any additional complaints related to this product.Image/video review: no image or video clip for the reported event was submitted for review.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the inner seal broke off and fell inside of a patient.The broken piece was retrieved with a grasper instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with a nurse and obtained the following additional information: the issue was noted during instrument insertion.The seal was in use for 1.5 hours.It is unknown if the seal was in contact with any other instruments or hard material during the case.The cannula was inspected prior to use.The seal was removed during the case but it is unknown if the wrist of the instrument was straightened during that time.There were no post-op tests performed to check if any fragments remained in the patient.There was no injury to the patient.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1: b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI X/XI ACCESSORY
• 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: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10497869
• Report Number: 2955842-2020-10871
• Device Sequence Number: 17050037
• Product Code: GCJ
• UDI-Device Identifier: 00886874112540
• UDI-Public: (01)00886874112540(10)M10200430
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 470361-05
• Device Catalogue Number: 470361
• Device Lot Number: M10200430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG