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

Model Number	470361-08
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.An return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the foreign object fell into the patient¿s abdominal cavity during the port placement.The customer removed all the instruments to inspect and found the cannula seal was damaged under the endoscope.It is unknown if the fragment was retrieved.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the cannula seal instrument was inspected prior to use, and no damage was found.The customer retrieved the fragments that appeared to have fallen but was unsure if all of them have been retrieved.The post-operative tests and additional surgical procedure were not performed.The surgical staff did not feel any resistance upon removal of the instrument through the cannula seal.It was unknown what caused the accessory to break and how broken they were, but there was no collision occurred during procedure.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The seal was analyzed and found to have damage in multiple areas.The accessory's upper housing was found to be broken.The broken pieces were not returned with the seal.The accessory's spacer/latch was also found to be broken.The damage was located on the grey levers.The complaint regarding physical damage was confirmed by failure analysis.

• Brand Name: NONE
• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18567398
• Report Number: 2955842-2024-10578
• Device Sequence Number: 20878839
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(17)250831(10)L82230901
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2024

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: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: L82230901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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: 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
• Patient Sex: Male