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

Model Number 470375

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

No product has been returned to intuitive surgical, inc.(isi) for evaluation and no malfunction of a da vinci product was reported.A system log review did not reveal any system errors that would have caused or contributed to the reported event.Field h4 is blank because insufficient product information was provided in order to obtain the date of manufacture.

Event Description

It was reported that during da vinci assisted a right upper lobectomy with a thoracoscopy and mediastinal lymph node dissection, the surgeon demonstrated the 12mm cannula rubbing against the rib when tented upwards and pointed out the bleeding at the beginning of the case.The port site of the 12mm cannula was noted after the case to be bruised due to the cannula rubbing against the rib (internally) above the intercostal space (ics).During follow up with the clinical sales representative (csr), it was stated that the bruising is occurring despite correct use of the remote center cannula indicators and said that it was typically caused by the angle needed on the universal surgical manipulator (usm) during stapling.

Manufacturer Narrative

Section b5 additional information: follow up was performed with the site rn robotics coordinator who reviewed the operative note and stated that there is no mention of a fracture or the reported cannula issue and the estimated blood loss for the procedure was 25ml.It was also noted that at some point post-operatively, the patient had "ripped his chest tube out".An x-ray performed on (b)(6) 2023 documents the chest tube findings and also "no acute skeletal findings." a second chest x-ray on (b)(6) 2023 also noted there were no acute skeletal findings.The patient was seen for questionable pneumonia on (b)(6) 2023 [12 days post-procedure], but the x-ray performed had no findings.Incidentally, the site rn noted that the patient expired on (b)(6) 2024 [approximately 3.5 months post-procedure] with the cause of death unknown and presumed unrelated to the surgical procedure and unrelated to reported cannula/bruising event.Section a: patient demographics added.

• Brand Name: NONE
• Type of Device: STAPLER CANNULA
• 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: 18165025
• MDR Text Key: 328480102
• Report Number: 2955842-2023-20430
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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: 470375
• Device Catalogue Number: 470375
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White