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

Model Number	478071-04
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the trocar part broke after assembling the seal.The trocar was removed and replaced with a backup.Following this, the customer continued and completed the procedure with no further issues.No fragment fell into the patient.No known impact or patient consequence was reported.Isi followed up with the initial reporter and obtained the following additional information: the customer confirmed that the issue occurred while assembling the single site seal onto the cannula.The cannula was completely detached.No fragment fell into the patient.The cannula was not used on the patient.The cannula was inspected before use, and no issues were detected.The customer confirmed that the cannula did not collide with any other hard material while assembling.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.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.Isi followed up with the initial reporter and obtained the following additional information: the customer confirmed that the issue occurred while assembling the single site seal onto the cannula.The cannula was completely detached.No fragment fell into the patient.The cannula was not used on the patient.The cannula was inspected before use, and no issues were detected.The customer confirmed that the cannula did not collide with any other hard material while assembling.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The curved cannula accessory was analyzed and found to be broken.The cannula was inspected, and it was found that the cannula's trocar was completely separated from the shaft.These components are manufactured together and should not be able to move independently or separate from one another.The complaint was confirmed by failure analysis.
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 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: 19235979
• Report Number: 2955842-2024-14140
• Device Sequence Number: 8106491
• Product Code: NAY
• UDI-Device Identifier: 00886874113684
• UDI-Public: (01)00886874113684(10)VE161602
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• 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): 04/11/2024

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: Health Professional
• Device Model Number: 478071-04
• Device Catalogue Number: 478071
• Device Lot Number: VE161602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2016
• 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 Sex: Prefer Not To Disclose