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

Model Number	470361-08
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the cannula seal involved in this complaint be returned for evaluation.However, the product has not yet been received.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided.This complaint is being reported due to the following conclusion: it was alleged that a blue fragment, which was suspected to be from the cannula seal, was visualized on top of an instrument that was inside the patient.The instrument was removed, but the fragment could not be located.At this time it is unknown what caused a fragment to break from the cannula seal and fall inside the patient.In addition, the location of the fragment, and whether it was retained inside the patient's anatomy, is unknown.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a blue fragment (approximately 1 mm in length) was seen on the shaft of the vessel sealer instrument while it was inside the patient.The operating room (or) team saw this on the screen of the vision cart and believed that it was a small fragment from the blue plastic seal (cannula seal).The surgeon reportedly "poked" at the fragment and noticed that it was loose on the instrument.When the or team removed the instrument, the fragment could not be found.It is unknown if the fragment was removed from the patient's body along with the instrument, or if the fragment was retained inside the patient's anatomy.There was no known impact or patient consequence reported.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information related to the event.However, no further details have been received as of the date of this report.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the cannula seal associated with this complaint and completed investigations.Failure analysis investigations did not confirm the reported complaint that a small fragment from the cannula seal was seen on a vessel sealer's shaft.During visual inspection, failure analysis did not find any damage to the seal.There were no tears or missing pieces observed.The blue rubber seal was internally inspected and did not exhibit damage.There was no problem detected.

• Brand Name: DA VINCI
• Common Device Name: CANNULA SEAL
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12573977
• Report Number: 2955842-2021-11249
• Device Sequence Number: 3787992
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)L10201210
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133845
• 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
• Report Date (Section B): 09/09/2021

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: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: L10201210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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: Initial
• 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.; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 89 KG