MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CANNULA, CURVED, CAM RIGHT

Model Number	478071-05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted endometriosis resection surgical procedure, the surgeon lost movement of the instrument.The instrument was removed with resistance and the sheath of the cannula remained in the patient.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the 5mm single site fenestrated bipolar was in use during the event.All the pieces were removed.The instrument was inspected prior to use and no damage or anything out of the ordinary was found.The surgical task being performed was dissecting and grasping.The instrument broke at the weld point on trocar after being in use for 3-4 hours.The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure.The instrument did not collide with any other instruments or other hard materials during the surgical procedure.The fragment(s) did not fall inside the patient during an instrument tip/accessory collision.The instrument was removed during the procedure (prior to the breakage) and the wrist was straightened prior to removal.The instrument was not able to be removed so the whole trocar had to be removed with the instrument.Trocar and the instrument were stuck and then removed together.The trocar was in 2 pieces on the instrument.The surgical staff did not notice any other damage to the instrument after the event occurred.The instrument and cannula were retrieved altogether.The fragments were retrieved, and it was visually confirmed.No additional surgeries were performed.No post-operative tests were done.The procedure was completed.No patient injury or harm.The patient did not return to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The cannula was returned.The instrument was not kept for return.No media is available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cannula accessory was analyzed and found to have the curved shaft detached from the bowl at the weld between the two components.The cannula could no longer be used.Mating surface of shaft with the bowl displayed indentations and ridges.The complaint was confirmed by failure analysis.
Additional Manufacturer Narrative
Further failure analysis (fa) investigation was performed, and the following information was obtained: the initial fa was confirmed, and the curved cannula exhibited a separated funnel and tube.Inspection of the two components found that the break was located after the weld portion, and towards the distal end where instruments exit.It appeared the tube itself had broken, and the welded portion was still within the funnel.There did not appear to be any missing pieces and the welds appeared to be nominal.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: CANNULA, CURVED, CAM RIGHT
• 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: 19029596
• Report Number: 2955842-2024-12871
• Device Sequence Number: 8167698
• Product Code: NAY
• UDI-Device Identifier: 00886874113684
• UDI-Public: (01)00886874113684(10)VE190401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• 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,Followup
• Report Date (Section B): 03/05/2024

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: 478071-05
• Device Catalogue Number: 478071
• Device Lot Number: VE190401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2019
• 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: 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 Age: 41 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American