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

Model Number 470361

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, it is unknown when the surgeon made the decision to convert the procedure due to the patient's anatomy.There was no allegation that a malfunction of a da vinci product caused or contributed to the injury.Intuitive surgical, inc.(isi) has not received the cannula seal ports accessory 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 instrument is returned (post-failure analysis evaluation) or if additional information is received.

Event Description

It was reported that during a da vinci-assisted surgical procedure that the cannula seal ports accessory was leaking gas.The issue was reported by the intuitive surgical, inc.(isi) clinical sales representative (csr).Reportedly the procedure was aborted/converted due to the patient's anatomy.The site will return material authorization (rma) the affected cannula seal ports accessory.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information, however, no further details have been received as of the date of this report.

• Brand Name: NONE
• Type of Device: 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: 17961207
• MDR Text Key: 325985430
• Report Number: 2955842-2023-19357
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/20/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 470361
• Device Catalogue Number: 470361
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES